A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer (NCT00913835), a randomized phase 2 study. The primary outcome is Progression-Free Survival (PFS).

2. Clinical Question

3. Trial Design

This was a randomized, phase 2, parallel-group trial with no masking. The registry lists an enrollment of 125. The primary analysis included 62 participants assigned to olaratumab plus liposomal doxorubicin and 61 assigned to liposomal doxorubicin with optional olaratumab monotherapy after progression. These analysis counts are consistent with the registry’s modified intent-to-treat definition, which included randomized participants who received any amount of study drug.

The treatment strategies differed in whether olaratumab was part of the initial combination. In the comparator strategy, liposomal doxorubicin was given as monotherapy until progression, after which olaratumab monotherapy was optional. The record does not establish how many participants took that option in the overall trial. A separate safety group is listed for participants receiving liposomal doxorubicin, and another for those in the optional olaratumab-monotherapy group; those entries should not be treated as additional randomized groups in the primary comparison.

The registry lists the study as completed. The recorded start is 2009-06 and the primary completion is 2011-10. The sponsor was Eli Lilly and Company. The allocation ratio, randomization procedure, treatment doses, and treatment schedules are not reported in the registry record. The registry record also does not report the original sample-size justification or planned interim analyses.

For the primary endpoint, the analysis population was the modified intent-to-treat population rather than every randomized participant regardless of treatment received. The record reports 13 participants censored in the combination group and 14 in the liposomal-doxorubicin group for progression-free survival. The censoring definition is described in the endpoint information; further detail on follow-up completeness and the handling of missing measurements is not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Participants from liposomal doxorubicin (Lip Dox) treatment group who had progressive disease (PD) had the option to receive to Olaratumab (Olara) monotherapy. Participants who had evidence of PD, died in either period, or received optional Olaratumab monotherapy from liposomal doxorubicin monotherapy were considered to have completed the study.

Olara+Lip Dox and Lip Dox Monotherapy

Reasons for not completing this period:

Lip Dox: Olaratumab Monotherapy

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Modified Intent to Treat (mITT) Population: All randomized participants who received any amount of study drug. Participants censored: Olaratumab=13, Liposomal Doxorubicin=14.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Modified Intent to Treat (mITT) Population: All participants who were randomized and received any quantity of study drug.

6. Primary Endpoint

The registry lists the primary outcome as Progression-Free Survival (PFS), measured over Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months).

Progression-free survival measures the time from randomization to the first evidence of disease progression or death from any cause. The registry defines progression using RECIST v1.0: a 20% increase over the smallest sum of target lesions or the appearance of new lesions. A participant who died without a previously reported progression was considered to have progressed on the date of death. The endpoint timeframe was randomization to progression or death, up to 35 months, and results are reported in weeks.

General: Time-to-event endpoints use both the timing of an event and information from participants who have not had the event by the end of their observed follow-up. Those participants may be censored rather than treated as if they had an event. In this trial, participants without progression who were subsequently lost to follow-up had their data censored at their last tumor assessment. This lets the analysis retain partial follow-up information, while making the interpretation dependent on the assumptions behind censoring.

Progression-free survival is used to compare how long participants remain alive without documented progression after randomization. It is distinct from overall survival, which measures time to death, and from response rate, which counts complete or partial responses. The primary endpoint’s time-to-event structure is why the principal reported comparison is a hazard ratio, rather than a simple difference in the number of participants with an event.

7. Results Posted in the Registry

• Olaratumab and Liposomal Doxorubicin vs Liposomal Doxorubicin: Optional Olaratumab Monotherapy: hazard ratio 1.05 (95% CI 0.75–1.48), reported p = 0.805 (as reported in the registry).

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Overall Survival (OS)

• Endpoint type: Time to event: compared as a hazard ratio.
• Test: Hazard ratio as reported by the sponsor (Log Rank); it was not recalculated.
• Result:
  • Olaratumab and Liposomal Doxorubicin vs Liposomal Doxorubicin: Optional Olaratumab Monotherapy: hazard ratio 1.11 (95% CI 0.77–1.62), reported p = 0.635 (as reported in the registry).
• Interpretation:
  • The 95% confidence interval includes no difference (a ratio of 1), so these data do not show a statistically significant difference between Olaratumab and Liposomal Doxorubicin vs Liposomal Doxorubicin: Optional Olaratumab Monotherapy and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Liposomal Doxorubicin: Optional Olaratumab Monotherapy: 16.4% (10/61) versus 12.9% (8/62) on control; risk difference 3.5 percentage points (95% CI -9.0 to 16.0), risk ratio 1.27 (0.54–3.00); unadjusted two-proportion z-test p = 0.584.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liposomal Doxorubicin: Optional Olaratumab Monotherapy and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Anti-Olaratumab Antibodies

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Liposomal Doxorubicin: Optional Olaratumab Monotherapy: 0.0% (0/20) versus 1.8% (1/57) on control; risk difference -1.8 percentage points (95% CI -5.2 to 1.7); unadjusted two-proportion z-test p = 0.551.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Liposomal Doxorubicin: Optional Olaratumab Monotherapy and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the questions beyond progression-free survival, including overall survival, tumor response, duration of response, adverse events, antibodies, post-progression olaratumab, and olaratumab exposure. The registry lists 12 secondary outcomes, but detailed numerical results are not available in the information summarized for every listed outcome. Values for outcomes without posted numerical results are not reported in the registry record.

The posted overall-survival and response results do not supply a clear, statistically significant contrast that changes the primary endpoint reading. They offer additional, distinct outcome summaries, but they do not resolve the uncertainty in the progression-free survival estimate. Overall survival measures time to death, whereas response rate concerns whether a complete or partial response was recorded; each addresses a different aspect of outcome and has its own limitations.

The antibody result is based on participants with available data in the listed groups, and the registry gives no comparative sponsor analysis for that endpoint. Other listed outcomes include duration of response, post-progression treatment, and pharmacokinetic measures. These outcomes may help characterize aspects of treatment and follow-up, but the registry record does not report enough numerical detail to draw a comprehensive secondary-outcome synthesis.

General: Secondary outcomes are often interpreted as supportive or exploratory, especially when several outcomes are examined. If many statistical tests are conducted, the chance of at least one apparently unusual result can increase. Unless a testing hierarchy or multiplicity adjustment is specified, an isolated secondary p-value should carry less weight than a prespecified primary analysis. The multiplicity plan is not reported in the registry record, so the secondary findings should be read cautiously and in the context of the primary result rather than as independent confirmation.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Overall Survival (OS)
• Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
• Median Duration of Response
• Number of Participants With Adverse Events (AEs) and Who Died
• Percentage of Participants With Anti-Olaratumab Antibodies
• PFS of Participants Who Received Olaratumab After Liposomal Doxorubicin Monotherapy (Descriptive Statistics for Safety and Efficacy for Participants Who Continue on Olaratumab Monotherapy Following Disease Progression on Liposomal Doxorubicin Monotherapy)
• Area Under the Curve (AUC) of Olaratumab
• Maximum Concentration (Cmax) of Olaratumab

9. Statistical Interpretation

10. Statistical Methods Explained

The primary comparison is a time-to-event analysis. The registry reports a log-rank test and a hazard ratio for progression-free survival. General: A time-to-event analysis uses the observed event times and can incorporate participants whose follow-up ends before an event is recorded. This is useful when participants have different lengths of follow-up, but it requires clear definitions of events and censoring. The registry defines progression and death as events and explains that some participants without progression were censored at their last tumor assessment.

What does the hazard ratio describe?

General: A hazard ratio compares the event rates between groups over follow-up, conditional on participants remaining at risk at each point. A value of 1 represents no difference in the relative hazard under the model; values on either side indicate different relative hazards, with direction depending on the group ordering and event definition. It is not a ratio of median survival times, and it does not directly state how many weeks an individual participant gains or loses. The posted estimate is 1.054 for olaratumab plus liposomal doxorubicin compared with liposomal doxorubicin with optional olaratumab after progression. Its 90% confidence interval is 0.751 to 1.478.

How does the log-rank test fit the comparison?

General: The log-rank test compares the observed pattern of events over time between groups, accounting for the number of participants still at risk as follow-up proceeds. It produces a test of whether the event experience differs under the null hypothesis. The registry reports p = 0.805 for the primary comparison. This value does not measure the size of a treatment effect and is not the probability that the null hypothesis is true. The hazard ratio and its interval give an estimate and uncertainty; the test result addresses the evidence against the null under the test’s assumptions.

What is the role of the median?

General: The median time-to-event value is the time by which half of the estimated event-time distribution has experienced the event. It offers an understandable summary, but it does not describe the entire distribution and can be imprecise when follow-up is limited or many observations are censored. The posted medians are 18.1 weeks and 17.3 weeks, with 90% confidence intervals of 8.7 to 27.0 weeks and 14.1 to 31.9 weeks. The medians should be read alongside the hazard ratio and its interval, rather than as a substitute for the time-to-event comparison.

Who was included in the primary analysis?

The registry defines the primary population as modified intent to treat: all randomized participants who received any amount of study drug. The reported group counts are 62 and 61. This differs from a strict analysis of every randomized participant regardless of treatment received. The registry record does not report a separate intention-to-treat estimate including any randomized participant who may not have received study drug, nor does it describe a per-protocol analysis.

General: Randomization helps make assigned groups comparable on average, while masking can reduce some risks of assessment or reporting bias. This trial is listed as randomized but with no masking. Because participants and study staff were not masked, knowledge of assigned strategy could potentially influence care, reporting, or assessments. The registry information does not establish whether or how such influences affected the recorded outcomes. Progression criteria are defined, which helps specify the endpoint, but the record does not report independent blinded review of progression assessments.

For the objective response rate secondary endpoint, the registry reports a Fisher exact test. General: Fisher’s exact test compares proportions in a two-group categorical outcome and is useful with small counts. An unadjusted re-calculation from the posted response counts gives a risk difference of 0.035 and a p-value of 0.584; the sponsor’s reported Fisher exact p-value is 0.619. These are not interchangeable results: they reflect different analyses, and the posted re-calculation is an unadjusted calculation from summary counts. The registry also reports log-rank hazard ratios for time-to-event outcomes. The original statistical analysis plan, including any covariate adjustment or prespecified testing hierarchy, is not reported in the registry record.

General: Over-dispersion is a concern when variability in count data exceeds what a chosen model assumes. It is not the defining issue for this trial’s primary endpoint, which is time to progression or death, rather than a count outcome. The registry’s use of a log-rank comparison and hazard ratio is consistent with a time-to-event question. The record does not report a proportional-hazards assessment or other diagnostic information; therefore, the suitability of model assumptions cannot be fully evaluated from the posted summary alone.

11. Confidence Intervals and Precision

The primary hazard ratio is 1.054, with a 90% confidence interval from 0.751 to 1.478. This interval includes 1 and extends across a range of possible relative hazards. It indicates that the point estimate is not precise enough to distinguish confidently between the null value and effects in either direction. The corresponding log-rank p-value is 0.805. Neither the interval nor the p-value establishes that the strategies are equivalent.

General: A confidence interval describes the uncertainty around an estimate under the statistical method used. A 90% confidence interval is not a statement that there is a 90% probability the true value lies inside this particular interval. Rather, the procedure is designed to produce intervals with the stated coverage over repeated use under its assumptions. The width of an interval reflects both the information in the data and the method’s assumptions.

The median estimates also have broad intervals: 8.7 to 27.0 weeks for the combination group and 14.1 to 31.9 weeks for the comparator group. Those ranges show that the group medians are estimated with meaningful uncertainty. Medians and the hazard ratio summarize different features of the event-time distributions, so their intervals answer related but not identical questions.

Precision is affected by the number and timing of observed events, follow-up, and censoring, not only by the number enrolled. The primary population comprised 62 and 61 participants, with 13 and 14 censored. The registry does not report all event counts or follow-up details needed to assess how each feature contributed to the interval width. The result is best read as an estimate with substantial uncertainty, rather than as a precise estimate of no difference.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not a record of the trial’s original design calculation. For the time-to-event outcomes, the figures are total events required; for the binary response outcome, they are participants per arm. Thus the progression-free survival and overall survival planning entries are event totals, while the response-rate entries refer to participants in each arm. The original sample-size justification and its assumptions are not reported in the registry record.

The illustration assumes a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It considers effects set at 100%, 75%, and 50% of the observed effect. The columns for 80% and 90% power describe the planned chance of detecting the stated effect, under those assumptions, if that effect were the true one. Higher power requires more information for the same effect, and the 90% power column therefore calls for more events or participants than the 80% column.

Smaller effects are harder to distinguish from random variation, so the rows for 75% and 50% of the observed effect require more events or participants than the row using 100% of the observed effect. For a time-to-event endpoint, the total event count is the planning target, not the number of participants per arm. For a binary endpoint, the per-arm target is not a total across both groups. The distinction matters when relating planning figures to an enrollment count.

These figures are not observed power. They are planning illustrations computed from the observed effect and the stated assumptions, and they do not show the probability that the completed trial’s result is correct. They should not be used to infer what the trial was originally designed to detect, because that original justification is not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

d is the total number of events needed (Schoenfeld's formula) with 1:1 allocation and proportional hazards.

Worked calculation for this trial

1. Hazard ratio HR = 1.054, so ln(HR) = 0.0526.
2. d = 4 × (1.96 + 0.842)² / [ln(1.054)]² = 11,350.7, rounded up to 11,351 events in total for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
hr <- 1.054                              # observed hazard ratio
events_needed <- function(power, frac = 1) ceiling(round(4 * (z_a + qnorm(power))^2 / log(hr^frac)^2, 6))   # Schoenfeld, 1:1 allocation
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: events = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(events_needed(0.80, f), big.mark = ","), format(events_needed(0.90, f), big.mark = ",")))

# Simulation: given d total events under proportional hazards, events in the treatment arm are Binomial(d, hr / (1 + hr)).
# The score (log-rank type) statistic is (D1 - d / 2) / sqrt(d / 4).
set.seed(913835)
d    <- events_needed(0.80)
reps <- 20000
D1 <- rbinom(reps, d, hr / (1 + hr))
z  <- (D1 - d / 2) / sqrt(d / 4)
cat(sprintf("Simulated power with %s events: %.3f (%d replicates)\n", format(d, big.mark = ","), mean(abs(z) > z_a), reps))

Output from running the code

100% of observed effect: events = 11,351 (80% power), 15,196 (90% power)
 75% of observed effect: events = 20,179 (80% power), 27,014 (90% power)
 50% of observed effect: events = 45,403 (80% power), 60,782 (90% power)
Simulated power with 11,351 events: 0.797 (20000 replicates)

The simulation uses the fact that, with d events in total and proportional hazards, the number of events in the treatment arm is binomial. It is an approximation that conditions on the total number of events, and it should land close to the target power.

14. Analyses Reported by the Sponsor

For progression-free survival, the posted hazard ratio is the sponsor-reported result: 1.054, with a 90% confidence interval of 0.751 to 1.478 and a log-rank p-value of 0.805. The time-to-event comparison is not independently recalculated from the displayed medians; a median alone does not contain the event-time and censoring information needed to reproduce a log-rank hazard ratio. The interpretation therefore relies on the sponsor’s reported analysis.

The registry also reports the sponsor’s Fisher exact p-value of 0.619 for objective response rate. The unadjusted re-calculation from the posted response summaries gives a risk difference of 0.035 and p = 0.584. The methods differ, so the two p-values should not be treated as duplicates or expected to match exactly. The recalculation is a simple unadjusted comparison of summary counts, whereas the registry identifies Fisher’s exact test for the sponsor analysis.

For overall survival, the sponsor-reported comparison is a hazard ratio of 1.115, with a 90% confidence interval of 0.768 to 1.618 and p = 0.635. These time-to-event estimates are presented as reported in the registry rather than reconstructed from arm medians. The registry does not provide enough detail to reproduce the sponsor’s full analysis or assess all of its assumptions.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 13 outcome measures and 3 reported analyses. The primary progression-free survival endpoint is identified, and results are also posted for selected secondary outcomes. The registry record does not report a prespecified hierarchy for testing these outcomes, a family of hypotheses, or a multiplicity adjustment. It is therefore not possible to determine from the record whether the secondary analyses were intended to confirmatory standards or were exploratory.

General: When multiple outcomes or comparisons are tested, the chance of obtaining at least one small p-value by chance can rise. Statistical approaches such as a testing hierarchy or adjustment can control that risk, but they may change how evidence is interpreted. Without a reported plan, each secondary p-value should not be treated as though it were the sole confirmatory test. The primary result remains the main basis for the trial’s central statistical question.

The primary endpoint description gives some information about missing follow-up: participants without progression who were subsequently lost to follow-up had their data censored at the day of their last tumor assessment. It also reports 13 censored participants in the combination group and 14 in the liposomal-doxorubicin group. The registry record does not report further detail on reasons for loss to follow-up, missing tumor assessments, or sensitivity analyses for alternative missing-data assumptions.

The modified intent-to-treat population includes randomized participants who received any amount of study drug. The record does not report an analysis of all randomized participants regardless of treatment received, or a detailed account of exclusions between randomization and analysis. The original sample-size justification, interim-analysis plan, and full statistical analysis plan are not reported in the registry record. These omissions limit assessment of whether the reported analyses follow a prespecified plan and how robust the findings are to different assumptions about missing data or analysis populations.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: nausea (7.1%), vomiting (7.1%), pyrexia (7.1%), small intestinal obstruction (6.6%), pulmonary embolism (6.6%).

The registry lists serious adverse events for 27 of 62 participants in the olaratumab and liposomal-doxorubicin group, 23 of 61 in the liposomal-doxorubicin group, and 14 of 28 in the group listed for liposomal doxorubicin with optional olaratumab monotherapy. The last group is associated with the optional post-progression treatment and should not be read as another randomized arm in the primary comparison. The record also lists other adverse events for 62 of 62, 60 of 61, and 27 of 28 participants in those respective safety groups.

Among the listed serious adverse-event terms, nausea, vomiting, and pyrexia are each reported as 7.1%; small intestinal obstruction and pulmonary embolism are each 6.6%; and abdominal pain is 4.9%. These are event-term figures, not a complete description of each participant’s clinical course. The registry record does not report death counts in the available safety summary. Adverse-event counts alone do not establish whether an event was caused by treatment, and detailed causal attribution is not reported in the registry record.

General: Safety counts depend on the population and exposure period used for reporting. They should be interpreted with their denominators and group definitions, not treated as a direct randomized efficacy comparison. The post-progression optional-treatment group has a different role from the original randomized comparison.

17. What the Result Does, and Does Not, Mean

The result addresses a specific question: whether the progression-free survival experience differed between assignment to olaratumab plus liposomal doxorubicin and assignment to liposomal doxorubicin with optional olaratumab after progression. The reported hazard ratio is 1.054, its 90% confidence interval is 0.751 to 1.478, and the log-rank p-value is 0.805. The posted analysis did not detect a statistically significant difference between those strategies.

That finding does not establish that the strategies are identical, nor does it prove that either strategy has no effect. The confidence interval includes the null value and permits a range of relative effects. A non-significant test is not an equivalence result; equivalence or non-inferiority requires a prespecified margin and an analysis designed for that question, neither of which is reported in the registry record.

The comparison is also specific to the treatment strategies as described. Olaratumab was included from the start in one group, while the other group received liposomal doxorubicin alone until progression and then had the option of olaratumab monotherapy. The record does not report how many participants in that arm used the option. Consequently, the randomized comparison should not be recast as a simple comparison of continuous exposure to olaratumab against no exposure.

The population was participants with platinum-refractory or platinum-resistant advanced ovarian cancer who were randomized and received any amount of study drug. The registry record does not support extending the result to other populations, treatment schedules, or clinical questions. The trial was unmasked, and details needed to assess every aspect of outcome evaluation and missing follow-up are not reported.

These are statistical findings, not medical advice. They describe the posted trial data and their uncertainty. Decisions about care require clinical context beyond this trial’s registry results.

18. Why This Trial Matters Statistically

This trial illustrates why a point estimate should not be read alone. The progression-free survival medians are relatively close, but the primary comparison is based on a time-to-event analysis that incorporates event timing and censoring. Its hazard ratio and confidence interval communicate both the estimated relative event rate and the uncertainty around that estimate. The p-value alone would not convey that range.

The trial also makes the analysis population consequential. The primary result applies to randomized participants who received any amount of study drug, rather than necessarily to every randomized participant. The registry reports censoring counts and a censoring rule, but does not provide the full follow-up information needed to evaluate all missing-data assumptions. Those features are part of the interpretation, not administrative details.

The comparator strategy included an option for olaratumab after progression. This matters statistically because the randomized question concerns assigned strategies, while subsequent treatment may differ from initial assignment. It is important to preserve that distinction when describing the comparison and when considering what the result can address.

Finally, the posted secondary outcomes span several types of measures, while the multiplicity plan is not reported in the registry record. The primary endpoint should therefore remain central, and secondary findings should not be treated as a collection of independent confirmations. Together, these features show how trial design, endpoint definition, analysis population, censoring, uncertainty, and testing plans shape the conclusions that can be drawn from a registry result.

19. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary comparison has a confidence interval that includes the null value and extends across a broad range of hazard ratios. The result is therefore not precise enough to exclude potentially meaningful differences in either direction. The trial enrolled 125 participants, and the primary analysis included 62 and 61 participants in the two groups. The registry does not report the original sample-size justification, so the intended detectable effect and the rationale for the enrollment target are not available.

The study was not masked. The registry defines progression using RECIST v1.0, but does not report whether progression assessments were independently reviewed or blinded to assignment. It also does not report full detail about follow-up completeness, reasons for censoring, or sensitivity analyses for missing observations. These omissions limit evaluation of possible assessment and censoring effects.

The comparator allowed optional olaratumab monotherapy after progression. The randomized result therefore pertains to the assigned strategies, and the registry record does not report overall uptake of the optional treatment in the comparator group. The safety listing for the optional monotherapy group is not a replacement for a randomized comparison of that treatment.

The registry record does not report the full statistical analysis plan, original design assumptions, interim analyses, or multiplicity procedures. It also does not report detailed numerical results for every listed secondary outcome. These limitations restrict assessment of prespecification, secondary-outcome robustness, and the broader pattern of results.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer — NCT00913835.
• Registry record last updated 2019-09-26; status last verified 2019-09.
• Results first posted 2017-04-14.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

23. Record Summary

NCT00913835 is a completed randomized phase 2 trial titled A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer. The sponsor was Eli Lilly and Company. The registry lists an enrollment of 125, a start date of 2009-06, and a primary completion date of 2011-10.

The trial compared olaratumab plus liposomal doxorubicin with liposomal doxorubicin followed by optional olaratumab monotherapy after progression. Its primary endpoint was progression-free survival in the modified intent-to-treat population. The posted hazard ratio was 1.054, with a 90% confidence interval of 0.751 to 1.478 and a log-rank p-value of 0.805. The result did not show a statistically significant difference between the assigned strategies; the interval indicates uncertainty rather than equivalence.