This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery (NCT03008278), a na phase 1, phase 2 study. The primary outcome is Dose Limiting Toxicity and Maximum Tolerated Dose of Olaparib (Phase I).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03008278 |
| Phase | Phase 1, Phase 2 |
| Condition | Metastatic Esophageal Carcinoma, Metastatic Gastric Carcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 51 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned patients with metastatic, recurrent, or unresectable gastric or gastroesophageal junction adenocarcinoma. The registry also lists esophageal cancer conditions. Its title describes metastatic or locally recurrent disease that cannot be removed by surgery. Enrollment was 51. The primary endpoint applied only to the Phase 1 portion; the registry describes 3 participants receiving Dose 1 and 6 receiving Dose 2, with 2 not evaluable.
Intervention
The treatment combined olaparib and ramucirumab. The registry describes olaparib by mouth twice daily on days 1–14 of each cycle and ramucirumab by intravenous infusion over 60 minutes on day 1. Cycles were scheduled to repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Comparator
There was no concurrent control group: the study is listed as single-group, with allocation recorded as NA and no masking. The registry’s background text mentions ramucirumab with paclitaxel or ramucirumab alone as comparisons of interest, but those are not listed as study arms. The Phase 1 dose levels and Phase 2 are not like-for-like control groups.
Primary question
The primary endpoint asks about dose-limiting toxicity and the maximum tolerated dose of olaparib in the Phase 1 portion. Toxicity was to be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, over up to 28 days. The registry record does not report a numerical result for this endpoint. It therefore does not establish from the listed primary outcome whether a dose-limiting toxicity occurred at a particular dose or what maximum tolerated dose was identified.
3. Trial Design
NCT03008278 is listed as a Phase 1/2, single-group study sponsored by the National Cancer Institute. The registry reports enrollment of 51 and a completed status. The recorded start date is 2018-02-06, and primary completion is listed as 2023-06-30. Its title describes olaparib in combination with ramucirumab for metastatic gastric and gastroesophageal junction adenocarcinoma.
The Phase 1 portion focused on dose-limiting toxicity and maximum tolerated dose. The registry describes participants receiving Dose 1 or Dose 2; it notes that 2 participants receiving Dose 2 were not evaluable for the primary endpoint. The primary endpoint timeframe was up to 28 days. The registry’s outcome description says that safety and adverse-event reporting were collected in an intent-to-treat analysis using data from all patients, and that safety was not planned to be evaluated or reported separately. It also clarifies that Phase 1 was a lead-in to Phase 2, rather than a separate arm for comparison.
The Phase 2 portion evaluated the combination in the single-group study. Listed secondary outcomes include progression-free survival, overall survival, outcomes by BROCA-HR status, and adverse events. The registry does not report a randomized allocation, masking, or a concurrent treatment comparator. Although the background text discusses possible comparisons with ramucirumab and paclitaxel or ramucirumab alone, those treatments are not study arms in the design described in the record.
The registry record does not report the planned statistical analysis, dose-escalation algorithm, stopping rules, or a sample-size justification. The enrollment figure describes the study record, but by itself does not explain how the study size was selected or what precision the investigators intended for any estimate.
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.
Overall Study
| Stage | PHASE 1 LEVEL 1 | PHASE 1 | PHASE 2 |
|---|---|---|---|
| STARTED | 3 | 8 | 40 |
| COMPLETED | 3 | 6 | 1 |
| NOT COMPLETED | 0 | 2 | 39 |
Reasons for not completing this period:
| Reason | PHASE 1 LEVEL 1 | PHASE 1 | PHASE 2 |
|---|---|---|---|
| Progressive Disease | 0 | 0 | 32 |
| Adverse Event | 0 | 0 | 4 |
| Withdrawal by Subject | 0 | 0 | 3 |
| Physician Decision | 0 | 2 | 0 |
Analysis population for the primary outcome, as defined in the registry: Only those in Phase 1 portion, 3 participants received Dose 1, 6 participants received Dose 2 (2 were not evaluable).
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.
| Characteristic | Unit | Phase 1: Treatment (Olaparib, Ramucirumab) LEVEL 1 | Phase 1: Treatment (Olaparib, Ramucirumab) LEVEL 2 | Phase 2: Treatment (Olaparib, Ramucirumab) | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 8 | 40 | 51 | |
| Age, Continuous | years | 46 (46 to 61) | 69 (38 to 82) | 65 (39 to 80) | 64 (38 to 82) |
| Sex: Female, Male: Female | Participants | 1 | 3 | 7 | 11 |
| Sex: Female, Male: Male | Participants | 2 | 5 | 33 | 40 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 1 | 6 | 35 | 42 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 1 | 3 | 6 |
| Region of Enrollment: United States | participants | 3 | 8 | 40 | 51 |
| ECOG Performance: 0 | Participants | 1 | 4 | 19 | 24 |
| ECOG Performance: 1 | Participants | 2 | 4 | 21 | 27 |
| Location of Primary Tumor: Gastroesophageal Junction | Participants | 1 | 4 | 26 | 31 |
| Location of Primary Tumor: Stomach | Participants | 2 | 4 | 4 | 10 |
| Location of Primary Tumor: Unreported | Participants | 0 | 0 | 10 | 10 |
| Previous Surgical Resection: Yes | Participants | 0 | 1 | 8 | 9 |
| Previous Surgical Resection: No | Participants | 3 | 7 | 32 | 42 |
| Histology: Well-differentiated | Participants | 1 | 0 | 2 | 3 |
| Histology: Moderately differentiated | Participants | 0 | 1 | 12 | 13 |
| Histology: Poorly differentiated | Participants | 2 | 6 | 22 | 30 |
| Histology: Not reported | Participants | 0 | 1 | 4 | 5 |
| Number of prior therapies: 1 | Participants | 1 | 4 | 18 | 23 |
| Number of prior therapies: 2 | Participants | 1 | 2 | 10 | 13 |
| Number of prior therapies: 3 | Participants | 1 | 2 | 8 | 11 |
| Number of prior therapies: >= 4 | Participants | 0 | 0 | 4 | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Dose Limiting Toxicity and Maximum Tolerated Dose of Olaparib (Phase I), measured over Up to 28 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Dose Limiting Toxicity and Maximum Tolerated Dose of Olaparib (Phase I).” It concerns participants in the Phase 1 portion and uses participants as the unit. Toxicity was to be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, over a timeframe of up to 28 days. The registry describes 3 participants receiving Dose 1 and 6 receiving Dose 2, with 2 in the latter group not evaluable for this endpoint.
In general, dose-limiting toxicity is used in early-phase studies to identify toxic effects that constrain dose selection. A maximum tolerated dose is a dose-selection concept based on the toxicity observed under a study’s specified assessment and decision rules. These definitions do not reveal what rule this study used: its dose-escalation method and decision criteria are not reported in the registry record.
The endpoint is relevant to dose selection, but the registry record does not give the endpoint’s numerical results. It does not state the number of dose-limiting toxicities by dose or report an identified maximum tolerated dose. The listed adverse-event counts are not a substitute for those endpoint results: they describe serious and other adverse events by registry group, while the primary endpoint is specifically about dose-limiting toxicity and maximum tolerated dose in Phase 1.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry information establishes the study’s broad design and clinical question, but it does not provide a numerical result for the primary endpoint. The endpoint is dose-limiting toxicity and maximum tolerated dose in Phase 1, with assessment planned over up to 28 days. Without reported endpoint counts or a reported dose decision, readers cannot determine from the registry record which dose, if any, met the study’s dose-selection criteria.
The study is listed as single-group, and the Phase 1 dose levels and Phase 2 are not a randomized comparison. Their outcome figures should not be read as if participants had been assigned to equivalent treatment arms for estimating a causal treatment effect. Dose level, study phase, eligibility, follow-up, and the purpose of each portion can differ. The registry itself describes Phase 1 as a lead-in to Phase 2. No concurrent control group is listed.
Progression-free survival and overall survival appear among the secondary outcomes, as do outcomes by BROCA-HR status and adverse events. The registry record does not provide numerical outcome estimates, confidence intervals, or analyses for these secondary outcomes. As a result, it does not support an interpretation of the size or precision of any survival association from the information recorded.
The adverse-event listing gives counts for serious events, other events, and deaths for Phase 1 Level 1, Phase 1 Level 2, and Phase 2. These are descriptive counts. They do not establish that an event was caused by treatment, and the death counts are not identified as deaths due to adverse events. The record does not report the event-level timing, duration, severity grading, or attribution needed for more detailed interpretation. The listed serious-event terms and percentages also lack a reported explanation of their denominator or whether the terms are exhaustive.
The registry’s background text describes a rationale for studying the combination and mentions other treatment regimens as potential points of comparison. That rationale is not evidence of a comparative result. In general, a single-group study can describe outcomes among enrolled participants, but separating treatment effects from the course of disease and other influences requires a suitable comparison and an analysis that accounts for the design. This record does not report such a comparison.
Any sample-size figures presented as planning illustrations should be understood as hypothetical design calculations based on an observed effect, not as the study’s original design justification or as observed power. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation, and a normal approximation. They do not turn this single-group study into a controlled comparison, and they do not supply missing clinical outcome estimates.
9. Statistical Methods Explained
What does the study design imply?
In general, a single-group study follows participants receiving a study treatment without a concurrent control group. It can describe observed outcomes and characterize safety in the enrolled population. It cannot, by design alone, show how those outcomes compare with what would have happened under another treatment or without the study treatment. The registry lists this study as single-group, with allocation recorded as NA and masking as none. No concurrent comparator is listed.
The Phase 1 dose levels and Phase 2 are parts of the study, not randomized arms. The registry describes Phase 1 as a lead-in to Phase 2. Comparisons across those groups can be difficult to interpret because participants may be enrolled for different purposes and at different stages of a study. The registry does not report an analysis designed to compare the groups, and the groups should not be treated as interchangeable controls.
What does the primary endpoint capture?
The Phase 1 primary endpoint concerns dose-limiting toxicity and maximum tolerated dose, with adverse events assessed using CTCAE version 5.0 over up to 28 days. In general, a structured toxicity grading system makes adverse-event reporting more consistent by defining categories of severity. Dose-finding studies use toxicity observations to inform dose selection. The exact method for making that decision depends on the study’s rules, which are not reported in the registry record.
The endpoint is recorded as a count of participants. A count conveys how many participants met an endpoint definition; interpretation also depends on the group being assessed, the endpoint definition, observation period, and handling of participants who cannot be evaluated. The record notes that 2 participants receiving Dose 2 were not evaluable for the primary endpoint. It does not explain how those observations were treated in a statistical analysis or report the endpoint counts by dose.
How should uncertainty be understood?
In general, a confidence interval describes a range of values compatible with the observed data under a statistical model and quantifies the precision of an estimate. A narrow interval indicates greater precision than a wide interval, while neither width nor the interval alone resolves bias or confounding. No confidence interval for the primary endpoint or listed secondary outcomes is reported in the registry record.
In general, estimates based on small groups can be imprecise, especially when outcomes are uncommon. A percentage or count without an uncertainty measure does not show how much the estimate might vary across comparable samples. The adverse-event listing gives group-specific counts, but it does not report confidence intervals or a comparative statistical analysis. Its descriptive figures should therefore be read as recorded counts rather than precise estimates of a general treatment effect.
Over-dispersion is a general statistical issue that occurs when variability in count data exceeds what a simple model assumes. If present, it can make standard errors too small and confidence intervals too narrow unless the analysis accounts for the extra variation. The registry does not report a model for count outcomes or information to assess over-dispersion. This concept is therefore relevant as a general consideration, not as a claim about this study’s data.
What do the planning illustrations mean?
In general, sample-size calculations describe how many participants or events a hypothetical study might require under stated assumptions about an effect, variability, allocation, and statistical testing. They are planning tools, not results from enrolled participants. The stated illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a fraction of the observed effect. For time-to-event outcomes, the illustration is based on a total event count; other illustrations are expressed as participants per arm.
Those assumptions do not describe the design of this registry study, which is listed as single-group and has no concurrent comparator. The illustrations are not the trial’s own design justification and are not observed power. The registry does not report a sample-size justification, the original effect assumption, or the analysis plan that would connect a hypothetical two-arm calculation to this study. Any such illustration should be treated as a planning exercise rather than a claim about what the study demonstrated.
What is not available for statistical review?
The registry record does not report analysis methods, model specifications, hypothesis tests, confidence intervals, or numerical primary endpoint results. It also does not state whether any interim analyses were conducted, how dose decisions were made, or how missing outcome data were handled. These omissions limit assessment of the study’s statistical precision and of how its planned questions were addressed. They do not establish that a particular method was or was not used outside what the registry reports.
The listed secondary outcomes include time-to-event outcomes such as progression-free survival and overall survival. In general, these outcomes describe time until a defined event, and their analysis depends on event definitions, follow-up, censoring rules, and methods for estimating uncertainty. Those details and corresponding estimates are not reported in the registry record. The outcome names alone are not enough to reconstruct an analysis or assess its precision.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists several secondary outcomes, including progression-free survival, overall survival, outcomes by BROCA-HR status, and adverse events. It does not report a multiplicity strategy. In general, testing or estimating multiple outcomes can increase the chance of apparently notable findings arising by chance if the analysis does not account for the number and structure of questions. A prespecified hierarchy, adjustment procedure, or clear separation of confirmatory and exploratory outcomes can help readers interpret multiple results. No such approach is reported in the registry record, and no numerical outcome analyses are listed.
Missing-data handling is also not reported. The record notes that 2 participants in the Phase 1 Dose 2 group were not evaluable for the primary endpoint, but it does not describe why they were not evaluable, how they were handled in the endpoint analysis, or whether sensitivity analyses were planned. In general, missingness can affect interpretation when participants without an observed outcome differ from those with one. The record does not provide enough information to assess whether that concern applies or how it was addressed.
The primary endpoint population is described as participants in the Phase 1 portion. Separately, the outcome description says safety and adverse-event reporting were collected in an intent-to-treat analysis using data from all patients, with no plan to evaluate or report safety separately. The record also says Phase 1 was a lead-in to Phase 2, not another arm. These descriptions distinguish the population relevant to dose finding from the stated overall safety reporting approach, but the registry does not give a detailed analysis-population specification for each outcome.
The registry lists 0 analyses. It does not report an analysis plan, the handling of missing data for the secondary outcomes, or whether multiplicity adjustments were applied. Those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| PHASE 1 LEVEL 1 | 2 | 3 | 66.7% |
| PHASE 1 LEVEL 2 | 3 | 8 | 37.5% |
| PHASE 2 | 11 | 40 | 27.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PHASE 1 LEVEL 1 | 3 of 3 |
| PHASE 1 LEVEL 2 | 7 of 8 |
| PHASE 2 | 21 of 40 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PHASE 1 LEVEL 1 | 3 of 3 |
| PHASE 1 LEVEL 2 | 8 of 8 |
| PHASE 2 | 40 of 40 |
Most frequent serious adverse event terms
| Event term | Organ system | PHASE 1 LEVEL 1 | PHASE 1 LEVEL 2 | PHASE 2 |
|---|---|---|---|---|
| Obstruction gastric | Gastrointestinal disorders | 0 of 3 | 1 of 8 | 2 of 40 |
| Multi-organ failure | General disorders | 1 of 3 | 0 of 8 | 1 of 40 |
| Hyponatremia | Metabolism and nutrition disorders | 0 of 3 | 0 of 8 | 2 of 40 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 0 of 3 | 0 of 8 | 2 of 40 |
| Heart failure | Cardiac disorders | 0 of 3 | 0 of 8 | 1 of 40 |
| Abdominal pain | Gastrointestinal disorders | 0 of 3 | 0 of 8 | 1 of 40 |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | 0 of 3 | 0 of 8 | 1 of 40 |
| Appendicitis perforated | Infections and infestations | 0 of 3 | 0 of 8 | 1 of 40 |
| Fracture | Injury, poisoning and procedural complications | 0 of 3 | 1 of 8 | 0 of 40 |
| Blood bilirubin increased | Investigations | 0 of 3 | 0 of 8 | 1 of 40 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PHASE 1 LEVEL 1 | PHASE 1 LEVEL 2 | PHASE 2 |
|---|---|---|---|---|
| Fatigue | General disorders | 1 of 3 | 5 of 8 | 31 of 40 |
| Nausea | Gastrointestinal disorders | 2 of 3 | 7 of 8 | 22 of 40 |
| Vomiting | Gastrointestinal disorders | 2 of 3 | 0 of 8 | 21 of 40 |
| Anorexia | Metabolism and nutrition disorders | 0 of 3 | 3 of 8 | 19 of 40 |
| Hypertension | Vascular disorders | 0 of 3 | 3 of 8 | 19 of 40 |
| Anemia | Blood and lymphatic system disorders | 1 of 3 | 3 of 8 | 17 of 40 |
| Constipation | Gastrointestinal disorders | 2 of 3 | 0 of 8 | 19 of 40 |
| Proteinuria | Renal and urinary disorders | 1 of 3 | 0 of 8 | 18 of 40 |
| Diarrhea | Gastrointestinal disorders | 0 of 3 | 4 of 8 | 14 of 40 |
| Abdominal pain | Gastrointestinal disorders | 1 of 3 | 0 of 8 | 16 of 40 |
Serious events with the highest arm-level rate: multi-organ failure (33.3%), respiratory failure (33.3%), obstruction gastric (12.5%), fracture (12.5%), neoplasms benign, malignant and unspecified (12.5%).
The registry lists serious-event counts for PHASE 1 LEVEL 1, PHASE 1 LEVEL 2, and PHASE 2, along with counts of participants at risk, counts with other adverse events, and deaths. For serious adverse events, the listed figures are 2 of 3 at risk for PHASE 1 LEVEL 1, 3 of 8 for PHASE 1 LEVEL 2, and 11 of 40 for PHASE 2. Other adverse events are listed for 3 of 3, 8 of 8, and 40 of 40, respectively. Deaths are listed as 3, 7, and 21, respectively.
These counts are descriptive, not a randomized comparison. The groups represent Phase 1 dose levels and Phase 2, not like-for-like control arms. The death counts are not stated to be adverse-event-related, and the registry does not report causality attribution for the listed events. The serious-event terms include Multi-organ failure and Respiratory failure, each listed at 33.3%; Obstruction gastric, Fracture, and Neoplasms benign, malignant and unspecified, each at 12.5%; and Hyponatremia at 5.0%. The denominator and whether these terms represent an exhaustive list are not reported in the registry record.
These figures should not be interpreted as estimates of comparative risk or as proof that treatment caused an event. The record does not provide the event timing, exposure duration, detailed severity, or statistical uncertainty needed for those conclusions.
12. What the Result Does, and Does Not, Mean
The record establishes that a Phase 1/2 study of olaparib with ramucirumab was conducted in metastatic or recurrent gastric or gastroesophageal junction cancer, and that the study is listed as completed. Its primary question concerned dose-limiting toxicity and maximum tolerated dose in Phase 1. The registry also identifies progression-free survival, overall survival, BROCA-HR status outcomes, and adverse events as secondary outcomes.
What the record does not establish is the numerical answer to its primary question. It does not report dose-limiting toxicity counts by dose or an identified maximum tolerated dose. Nor does it give numerical progression-free or overall survival results, or estimates of uncertainty for those outcomes. The presence of an outcome name in a registry is not itself evidence of a favorable, unfavorable, or precise result.
The combination was not tested against a concurrent randomized comparator in the design described. Therefore, the record does not provide a controlled estimate of how outcomes would differ under another treatment. The background text names ramucirumab with paclitaxel and ramucirumab alone as potential points of comparison, but these are not listed as study arms. Descriptive outcomes from a single group cannot by themselves separate treatment effects from other influences on outcomes.
The adverse-event figures describe counts recorded in registry groups. They do not identify whether deaths were caused by treatment, and they do not provide a controlled comparison of safety. The listed serious-event terms and percentages are also insufficient to determine event attribution or the complete safety profile.
In general, a clinical trial can inform a question only to the extent that its design, outcome definitions, analysis, and reported results support an estimate. Here, the registry describes the design and selected safety counts but does not report the primary endpoint result or the statistical analyses needed to assess precision. The record therefore supports a description of the study’s question and structure, not a conclusion about the treatment’s efficacy or a comparative safety effect.
13. Why This Trial Matters Statistically
This study is statistically notable as a single-group Phase 1/2 investigation that links early dose assessment with a later study portion. Its primary endpoint is a dose-finding question, whereas its listed secondary outcomes include survival and adverse-event measures. Keeping these roles distinct matters: a dose-limiting toxicity endpoint is not interchangeable with a survival endpoint, and Phase 1 dose levels are not control arms for Phase 2.
The registry’s description that Phase 1 was a lead-in to Phase 2 helps clarify why the listed groups should not be treated as a randomized comparison. When group labels reflect study phases or dose levels, differences in observed counts may reflect differences in participants, follow-up, or study purpose as well as any treatment-related factors. The record does not report an analysis that adjusts for such differences or supports causal comparisons.
The record also illustrates why outcome names and registry status alone are not enough to evaluate evidence. Although the primary endpoint and secondary outcomes are named, numerical primary endpoint and survival results are not reported in the registry record. Without estimates and uncertainty measures, readers cannot assess the magnitude or precision of those outcomes. The adverse-event counts add descriptive safety information but do not supply causal attribution or comparative risk.
Finally, hypothetical sample-size calculations should be kept separate from the actual study design. The stated calculations assume a two-arm allocation, while this study is listed as single-group. Treating such planning illustrations as observed power or as confirmation of a planned analysis would confuse design calculations with trial findings. Clear separation of observed data, analysis assumptions, and unreported results is essential to a statistically sound reading of this record.
14. 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 registry record does not report numerical results for the primary endpoint, including dose-limiting toxicity counts by dose or the maximum tolerated dose. It also does not provide numerical results for the listed progression-free survival, overall survival, or BROCA-HR status outcomes. As a result, the efficacy and dose-finding questions cannot be evaluated from the outcome information recorded.
The single-group design has no concurrent control arm. The Phase 1 dose levels and Phase 2 are not randomized, like-for-like comparison groups. The background text’s mention of other regimens does not make them study comparators. The design therefore does not support a causal comparison with those regimens.
The record does not report the dose-escalation rules, statistical analysis plan, sample-size justification, interim analysis approach, or methods for handling missing data. It identifies 2 participants in the Phase 1 Dose 2 group as not evaluable for the primary endpoint but does not describe the reason or analytic handling. This limits assessment of the endpoint’s interpretation and robustness.
Safety interpretation is also constrained. The registry gives counts and selected serious-event terms, but does not report event attribution, timing, duration, complete severity details, or the denominator context for the listed percentages. Deaths are listed, but their relationship to adverse events is not reported. The record’s statement about overall intent-to-treat safety reporting does not supply the numerical safety outcome analyses.
Finally, the registry describes enrollment and status but does not establish how representative the participants were of other populations with these cancers. The findings, even if fully reported elsewhere, would need to be interpreted in light of the single-group design, population, follow-up, and analysis methods. Those additional details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery — NCT03008278.
- Registry record last updated 2026-02-03; status last verified 2026-01.
- Results first posted 2025-06-04.
- 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.
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18. Record Summary
NCT03008278 is a completed, National Cancer Institute-sponsored Phase 1/2, single-group study of olaparib with ramucirumab for metastatic or recurrent gastric or gastroesophageal junction cancer. The registry lists enrollment of 51 and describes Phase 1 as a lead-in to Phase 2.
The primary endpoint was dose-limiting toxicity and maximum tolerated dose of olaparib in Phase 1, assessed using CTCAE version 5.0 over up to 28 days. The record notes 3 participants at Dose 1 and 6 at Dose 2, with 2 not evaluable. Numerical results for this primary endpoint are not reported in the registry record.
Listed secondary outcomes include progression-free survival, overall survival, BROCA-HR status outcomes, and adverse events. The record includes descriptive adverse-event counts but no concurrent comparator or reported statistical analyses. Missing-data methods, multiplicity handling, and the analysis plan are not reported.