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 Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas (NCT02037230), a na phase 1, phase 2 study. The primary outcome is Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02037230 |
| Phase | Phase 1, Phase 2 |
| Condition | Adenocarcinoma of the Pancreas |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan Rogel Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with unresectable adenocarcinoma of the pancreas. The registry record says participants who received at least one dose of study drug were evaluable for the maximum tolerated dose.
Intervention
AZD1775, also called MK-1775, given with gemcitabine and radiation therapy. The trial examined escalating AZD1775 dose levels in this combination.
Comparator
There was no separate control group: the allocation is listed as NA and the model as single group. Dose levels were part of the escalation design, not a like-for-like randomized comparison.
Primary question
What maximum tolerated dose of AZD1775 could be used concurrently with gemcitabine and radiation therapy? The registry record identifies dose level 1, 150 mg, as the maximum tolerated dose and recommended phase 2 dose.
The trial concerned an investigational combination for unresectable pancreatic adenocarcinoma. The registry describes the investigators’ long-term goal as improving survival by adding the Wee1 inhibitor MK-1775 to gemcitabine-radiation. That statement gives the rationale; it is not itself a reported finding about survival or treatment benefit.
The primary question was about dose selection and dose-limiting toxicity, rather than a comparison of survival or disease progression between treatment groups. The registry defines the maximum tolerated dose observation period as the first 4 cycles of treatment, with a 3 week break between cycle 3 and cycle 4, for a total of 105 days. The target dose-limiting toxicity rate was 0.30.
The study also listed phosphorylation inhibition, overall survival, and time from registration to documented disease progression as secondary outcomes. Numerical results for those outcomes are not reported in the registry record. With no randomized control group, the record does not establish a comparative treatment effect against another regimen.
3. Trial Design
This was a phase 1/phase 2, single-group dose-escalation trial of AZD1775 with gemcitabine and radiation therapy in patients with unresectable adenocarcinoma of the pancreas. The registry lists allocation as NA and masking as none. It records enrollment of 34 and a completed status. The listed start is 2014-01 and primary completion is 2018-08.
The intervention listing names MK-1775, gemcitabine, and radiation therapy. The treatment arm is described as AZD-1775 with gemcitabine and radiation therapy. Adverse-event records are grouped by AZD-1775 dose levels of 100 mg, 125 mg, 150 mg, and 175 mg. These dose groups belong to the escalation context; they are not randomized treatment and control arms. The registry explicitly cautions that the arms are not a like-for-like control comparison.
The primary endpoint was the maximum tolerated dose of AZD1775 when used concurrently with gemcitabine and radiation therapy. The record says the probability of dose-limiting toxicities was calculated for each dose using the Time to Event Continual Reassessment Method, or TITE-CRM. It identifies dose level 1, 150 mg, as both the maximum tolerated dose and the recommended phase 2 dose.
Participants who received at least one dose of study drug were evaluable for the maximum tolerated dose. The registry record does not report the full dose-escalation sequence, the numbers assigned to each dose, or whether every participant contributed complete observation through the specified period. Details of any other analysis populations, eligibility criteria, or treatment administration schedule are not reported in the registry record.
Although the registry lists phase 1 and phase 2, it does not report a separate randomized phase 2 comparison or numerical phase 2 efficacy results. The secondary outcomes include phosphorylation inhibition, overall survival, and time to documented disease progression. Their numerical results and associated analyses are 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.
Overall Study
| Stage | AZD-1775 100 mg | AZD-1775 125 mg | AZD-1775 150 mg | AZD-1775 175 mg |
|---|---|---|---|---|
| STARTED | 1 | 13 | 9 | 11 |
| Completed 4 Cycles of Treatment | 1 | 9 | 7 | 9 |
| COMPLETED | 0 | 7 | 3 | 5 |
| NOT COMPLETED | 1 | 6 | 6 | 6 |
Analysis population for the primary outcome, as defined in the registry: All participants who received at least one dose of the study drug were evaluable for MTD.
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 | AZD-1775 100 mg | AZD-1775 125 mg | AZD-1775 150 mg | AZD-1775 175 mg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 1 | 13 | 9 | 11 | 34 | |
| Age, Continuous | years | 74 | 66 (54 to 78) | 62 (44 to 74) | 60 (52 to 73) | 68 (44 to 78) |
| Sex: Female, Male: Female | Participants | 1 | 6 | 4 | 4 | 15 |
| Sex: Female, Male: Male | Participants | 0 | 7 | 5 | 7 | 19 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 | 11 | 9 | 10 | 31 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 0 | 0 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 1 | 13 | 7 | 11 | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy., measured over The observation period for MTD is defined as the first 4 cycles of treatment (with a 3 week break between cycle 3 and cycle 4), for a total of 105 days in length..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was the maximum tolerated dose of AZD1775 (MK-1775) when given concurrently with gemcitabine and radiation therapy. The registry defines the observation period for this endpoint as the first 4 cycles of treatment, including a 3 week break between cycle 3 and cycle 4, spanning 105 days. Participants who received at least one dose of study drug were evaluable for this endpoint.
The endpoint is intended to guide dose selection in a combination regimen. In general, a maximum tolerated dose is selected by considering the frequency or probability of dose-limiting toxicities at different dose levels. The registry says that dose-specific probabilities were calculated using TITE-CRM and identifies a target dose-limiting toxicity rate of 0.30. This statistical target is part of the dose-finding method; it is not a statement that the observed toxicity rate was 0.30.
The record reports the selected dose as dose level 1, 150 mg, and calls it the recommended phase 2 dose as well as the maximum tolerated dose. It does not provide numerical dose-specific toxicity probabilities, uncertainty intervals, or a count of dose-limiting toxicities by dose. Therefore, the registry summary supports reporting the sponsor’s stated dose selection, but it does not allow readers to reconstruct the dose-finding analysis or assess its precision from the posted information.
This endpoint addresses tolerability and dose selection, not whether the combination improves survival, disease control, or another clinical outcome. Results for those questions are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central reported result is a dose-selection result: the registry states that AZD1775 dose level 1, 150 mg, was determined to be the maximum tolerated dose and recommended phase 2 dose when used with gemcitabine and radiation therapy. The dose-limiting toxicity target was 0.30, and dose-specific probabilities were calculated with TITE-CRM. The registry does not give the underlying probabilities or uncertainty intervals, so the strength and precision of the dose-selection evidence cannot be independently judged from the posted summary.
The design was single group, with allocation listed as NA and masking as none. Participants treated at different AZD1775 dose levels were part of an escalation process, not randomized comparison groups. Differences between their adverse-event counts cannot be interpreted as causal dose effects without accounting for the way doses were assigned and the lack of a control group. The record itself cautions against treating the arms as like-for-like controls.
The adverse-event data list participants at risk and affected for serious events and other events separately within each dose group. For example, the registry reports serious-event counts of 1 at risk and 1 affected for AZD-1775 100 mg; 13 and 5 for 125 mg; 9 and 4 for 150 mg; and 11 and 8 for 175 mg. These are dose-group records, not evidence that all events were caused by study treatment. The record does not report the event-level timing, duration, attribution, or whether people had more than one event.
The listed serious-event terms include GI bleed at 100.0%, febrile neutropenia and fatigue at 27.3% each, fever at 22.2%, anorexia, nausea/vomiting at 18.2%, and colitis at 15.4%. The denominator and calculation basis for these percentages are not stated in the registry record. They should therefore be read as reported percentages attached to event terms, not as rates that can be directly compared across dose groups or interpreted as population risks.
The registry also lists deaths by dose group, but these counts alone do not show when deaths occurred, their causes, or whether they were considered related to treatment. Numerical results for overall survival, disease progression, and phosphorylation inhibition are not reported in the registry record. Accordingly, the posted information does not establish a survival or efficacy effect, and it does not permit a controlled comparison with another treatment.
9. Statistical Methods Explained
What does TITE-CRM do?
The registry says dose-limiting toxicity probabilities were calculated for each dose using the Time to Event Continual Reassessment Method, abbreviated TITE-CRM. In general, this is a dose-finding approach designed for settings where toxicity may take time to appear. It uses available follow-up information while participants are still being observed, rather than requiring every participant’s full toxicity observation period to finish before dose decisions can be considered. This general description explains the method’s purpose; the registry record does not report the trial’s detailed implementation or dose-assignment decisions.
The stated observation period for the maximum tolerated dose was the first 4 cycles, with a 3 week break between cycle 3 and cycle 4, for 105 days. The registry identifies a target dose-limiting toxicity rate of 0.30. In general, a target rate is a design aim used to guide dose selection; it is not necessarily the observed rate at the selected dose. The record reports that dose level 1, 150 mg, was selected as the maximum tolerated dose and recommended phase 2 dose, but does not publish the dose-specific toxicity probabilities, their uncertainty, or the detailed evidence leading to that selection.
What does the target rate mean?
In general, a dose-finding study balances the aim of selecting a dose that can be taken forward against the possibility of dose-limiting toxicity. A target toxicity rate provides a reference point for that decision. It does not, on its own, describe how many participants experienced toxicity, how severe the events were, or how precisely the selected dose’s risk was estimated. Those details are not fully reported in the registry record.
Why is the design not a comparative efficacy test?
The record identifies the model as single group, allocation as NA, and masking as none. Dose levels in an escalation study are not equivalent to randomized arms. Participants may have received a dose as part of the evolving dose-finding process, and the registry gives no basis for treating the dose groups as exchangeable controls. In general, a comparison of outcomes across nonrandomized dose groups can reflect differences in who received each dose, follow-up, or treatment sequence as well as any dose-related effect. The record cautions that the arms are not a like-for-like control comparison.
The primary endpoint was dose selection, not a treatment effect against a concurrent comparator. The registry lists overall survival, disease progression, and phosphorylation inhibition as secondary outcomes, but numerical outcome results and analysis details are not reported. No comparative effect estimate or confidence interval for these outcomes is available in the registry record.
How should uncertainty be assessed?
In general, an uncertainty interval describes a range of values compatible with an estimate under the analysis assumptions. It helps readers distinguish a point estimate from the precision of the evidence. The registry record does not report uncertainty intervals for the selected dose or dose-specific toxicity probabilities. It also does not report enough detail to calculate them without making unsupported assumptions. The stated selection of 150 mg should therefore be attributed to the registry’s reported analysis, rather than treated as a fully reproducible estimate from the summary.
The record says participants who received at least one dose were evaluable for the maximum tolerated dose. It does not state how incomplete observation was handled in the analysis, how toxicity events were defined for this purpose, or whether any other analysis populations were used. TITE-CRM is generally suited to handling follow-up that accrues over time, but the specific weighting, model assumptions, and operating characteristics used in this trial are not reported in the registry record.
What do the safety counts describe?
The registry provides dose-group counts at risk and affected for serious adverse events and other adverse events. In general, a count of affected participants is a descriptive safety measure; it does not by itself identify whether an event was treatment-related, how long it lasted, or whether one participant experienced more than one event. The record’s serious-event terms are accompanied by percentages, but their denominator and calculation basis are not stated. They should not be converted into dose-specific incidence estimates or used for dose comparisons without that information.
The listed death counts are also descriptive. In general, a count of deaths cannot substitute for a time-to-event analysis, which takes account of event timing and follow-up. Although overall survival appears among the secondary outcomes, numerical survival results and analysis methods are not reported in the registry record.
Are there other statistical details?
The registry record does not report a statistical analysis plan, sample-size justification, interim analysis plan, or details of multiplicity control. It lists 0 analyses. That entry does not explain whether analyses were not conducted, were not entered in the registry, or were unavailable in the posted results. The record lists 4 outcome measures, but does not supply numerical results for the secondary outcomes. These omissions limit independent evaluation of the analysis and should not be filled in by assuming a conventional plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary maximum tolerated dose endpoint and secondary outcomes for phosphorylation inhibition, overall survival, and time from registration to documented disease progression. It also records 4 outcome measures and 0 analyses. Numerical results for the secondary outcomes are not reported in the registry record.
Multiplicity concerns arise in general when a study makes several statistical assessments, because the chance of at least one apparently notable result can increase as more assessments are made. The registry record does not report whether multiplicity was addressed, whether secondary outcomes were considered exploratory, or what inferential procedures were planned. It would be inappropriate to infer an adjustment method or claim that no adjustment was used.
The record does not report a statistical analysis plan, the timing of any interim analyses, or a sample-size justification. It is also not clear from the posted information how incomplete follow-up was handled for the dose-finding endpoint or for time-to-event outcomes. These items are not reported in the registry record.
For the maximum tolerated dose endpoint, the registry states that participants receiving at least one dose were evaluable. It does not describe other analysis populations, exclusions, or the number of participants contributing to each outcome. Enrollment of 34 should not be assumed to equal the analysis population for every endpoint. Without those details and numerical outcome results, readers cannot assess missingness, outcome-specific denominators, or how much the available analysis may depend on participants with complete follow-up.
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 |
|---|---|---|---|
| AZD-1775 100 mg | 1 | 1 | 100.0% |
| AZD-1775 125 mg | 5 | 13 | 38.5% |
| AZD-1775 150 mg | 4 | 9 | 44.4% |
| AZD-1775 175 mg | 8 | 11 | 72.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AZD-1775 100 mg | 1 of 1 |
| AZD-1775 125 mg | 9 of 13 |
| AZD-1775 150 mg | 5 of 9 |
| AZD-1775 175 mg | 6 of 11 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| AZD-1775 100 mg | 0 of 1 |
| AZD-1775 125 mg | 3 of 13 |
| AZD-1775 150 mg | 3 of 9 |
| AZD-1775 175 mg | 4 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | AZD-1775 100 mg | AZD-1775 125 mg | AZD-1775 150 mg | AZD-1775 175 mg |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | 0 of 1 | 1 of 13 | 0 of 9 | 3 of 11 |
| Anorexia, nausea/vomiting | Gastrointestinal disorders | 0 of 1 | 1 of 13 | 0 of 9 | 2 of 11 |
| Fatigue | General disorders | 0 of 1 | 0 of 13 | 0 of 9 | 3 of 11 |
| Fever | General disorders | 0 of 1 | 0 of 13 | 2 of 9 | 1 of 11 |
| Cholangitis | Gastrointestinal disorders | 0 of 1 | 0 of 13 | 1 of 9 | 1 of 11 |
| Colitis | Gastrointestinal disorders | 0 of 1 | 2 of 13 | 0 of 9 | 0 of 11 |
| Septic shock | Blood and lymphatic system disorders | 0 of 1 | 0 of 13 | 1 of 9 | 1 of 11 |
| Abdominal Pain | Gastrointestinal disorders | 0 of 1 | 1 of 13 | 0 of 9 | 0 of 11 |
| ALT/AST elevation | Gastrointestinal disorders | 0 of 1 | 1 of 13 | 0 of 9 | 0 of 11 |
| Diverticulitis | Gastrointestinal disorders | 0 of 1 | 0 of 13 | 0 of 9 | 1 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AZD-1775 100 mg | AZD-1775 125 mg | AZD-1775 150 mg | AZD-1775 175 mg |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | 0 of 1 | 1 of 13 | 1 of 9 | 1 of 11 |
| Pruritic Rash | Skin and subcutaneous tissue disorders | 0 of 1 | 1 of 13 | 0 of 9 | 1 of 11 |
| Fatigue | General disorders | 0 of 1 | 1 of 13 | 0 of 9 | 1 of 11 |
| Fever | General disorders | 0 of 1 | 0 of 13 | 1 of 9 | 0 of 11 |
| Abdominal Pain | Gastrointestinal disorders | 0 of 1 | 0 of 13 | 1 of 9 | 0 of 11 |
| Edema | General disorders | 0 of 1 | 0 of 13 | 0 of 9 | 1 of 11 |
Serious events with the highest arm-level rate: gi bleed (100.0%), febrile neutropenia (27.3%), fatigue (27.3%), fever (22.2%), anorexia, nausea/vomiting (18.2%).
The registry reports adverse-event information by AZD-1775 dose group. For serious adverse events, it gives the number at risk and the number affected; it provides a separate at-risk and affected count for other adverse events. For example, in the 150 mg group, 9 were at risk for serious adverse events and 4 were affected, while 9 were at risk for other adverse events and 3 were affected. These are descriptive counts, not comparisons from a randomized safety analysis.
The listed serious-event terms and percentages are GI bleed, 100.0%; febrile neutropenia, 27.3%; fatigue, 27.3%; fever, 22.2%; anorexia, nausea/vomiting, 18.2%; and colitis, 15.4%. The registry does not state the denominator or calculation basis for these percentages. Their meaning cannot be assumed to match the dose-group at-risk counts.
In general, an adverse-event count does not establish that treatment caused the event. The record does not report event attribution, timing, duration, or whether affected participants experienced multiple events. Death counts are listed by dose group, but causes and relationship to treatment are not reported in the registry record. The counts should be read as safety descriptions, not as proof of causation or comparative risk.
12. What the Result Does, and Does Not, Mean
The registry’s main reported conclusion is that AZD1775 dose level 1, 150 mg, was selected as the maximum tolerated dose and recommended phase 2 dose with gemcitabine and radiation therapy. The dose-finding approach used TITE-CRM to calculate dose-specific probabilities of dose-limiting toxicities, with a target rate of 0.30. The maximum tolerated dose observation period was defined as the first 4 cycles, including a 3 week break between cycle 3 and cycle 4, spanning 105 days.
This result concerns dose selection in the trial’s combination regimen. It does not establish that the combination improves survival, controls disease, or is superior to another regimen. The registry lists overall survival and disease progression as secondary outcomes, but numerical results for these outcomes are not reported in the registry record. The investigators’ long-term goal is not evidence that the goal was achieved.
The study was single group, with allocation listed as NA and masking as none. Its dose groups should not be read as randomized comparators. Adverse-event counts and listed event percentages offer descriptive safety information, but the record does not give enough context to establish causality, compare groups fairly, or determine the denominator for the event-term percentages.
The record also does not report the dose-specific toxicity probabilities or their uncertainty. This limits independent assessment of how precisely the selected dose met the target toxicity level. The reported selection can be stated as the registry’s conclusion, but readers cannot recreate the underlying dose-finding analysis from the posted summary.
Overall, the available information supports a description of a completed dose-escalation study and its reported dose selection. It does not support a conclusion about comparative efficacy or a complete evaluation of safety and statistical uncertainty.
13. Why This Trial Matters Statistically
This trial illustrates that a study’s primary statistical question may be dose selection rather than a treatment-versus-control effect. The endpoint was the maximum tolerated dose of AZD1775 in combination with gemcitabine and radiation therapy. The registry reports a target dose-limiting toxicity rate of 0.30 and use of TITE-CRM, a method intended in general to support dose decisions while toxicity follow-up is accruing.
That design context matters when interpreting the groups. The adverse-event records are organized by AZD-1775 dose, but the registry identifies the study as single group and warns that the arms are not a like-for-like control comparison. A difference between dose-group counts cannot be treated as a randomized estimate of dose effect. The dose-selection conclusion is also distinct from evidence that the regimen improves clinical outcomes.
The trial is a useful example of why a reported dose recommendation and the underlying evidence should be distinguished. The record states that 150 mg was selected as the maximum tolerated dose and recommended phase 2 dose, yet it does not report dose-specific toxicity probabilities or uncertainty intervals. Those omissions prevent a reader from independently assessing the precision of the selection.
Finally, the registry lists several secondary outcomes but gives no numerical results for them. Statistical interpretation therefore depends on identifying both what the record does report and what remains unavailable. This helps prevent a dose-finding result from being overstated as a comparative efficacy finding.
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 summary does not provide the numerical dose-specific probabilities of dose-limiting toxicity, uncertainty intervals, or the detailed information needed to reproduce the TITE-CRM analysis. Although it reports the selected dose and target toxicity rate, the basis and precision of that selection cannot be independently assessed from the posted record.
Allocation is listed as NA, the model as single group, and masking as none. There is no randomized control group for comparison. The dose groups arise within an escalation trial, and the registry explicitly says they are not a like-for-like control comparison. Their adverse-event counts therefore should not be interpreted as controlled estimates of dose-related risk.
The record does not report numerical results for phosphorylation inhibition, overall survival, or disease progression. It also does not report outcome-specific denominators, detailed analysis populations beyond the MTD evaluability definition, or how missing follow-up was handled. Enrollment of 34 does not establish the analysis population for each endpoint.
Safety reporting is limited by the absence of event attribution, timing, duration, and an explanation of the denominators for serious-event percentages. Death counts are listed, but their causes and relationship to treatment are not reported. The statistical analysis plan, sample-size justification, interim analysis plan, and multiplicity procedures are also not reported in the registry record.
These limitations describe the information available in the registry record; they do not establish that a particular analysis or procedure was absent from the conduct of the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas — NCT02037230.
- Registry record last updated 2020-02-17; status last verified 2020-02.
- Results first posted 2020-02-17.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02037230 is a completed phase 1/phase 2, single-group dose-escalation trial of AZD1775 (MK-1775) with gemcitabine and radiation therapy for unresectable adenocarcinoma of the pancreas. The registry lists enrollment of 34, a start of 2014-01, and primary completion in 2018-08. Allocation is listed as NA and masking as none.
The primary endpoint was the maximum tolerated dose of AZD1775 used concurrently with gemcitabine and radiation therapy. The registry reports use of TITE-CRM, a target dose-limiting toxicity rate of 0.30, and an observation period of 105 days. Dose level 1, 150 mg, is reported as the maximum tolerated dose and recommended phase 2 dose.
Secondary outcomes include phosphorylation inhibition, overall survival, and time to documented disease progression. Their numerical results are not reported in the registry record. Adverse-event counts are recorded by dose group, but the groups are not randomized comparators.