Trial · NCT03261947
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
NCT03261947, Phase 2, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2021-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors. Trials, record NCT03261947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03261947
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
- NCT number
- NCT03261947
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 101 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Metastatic Pancreatic Cancer, Colorectal Cancer, Esophageal Neoplasms, Carcinoma, Non-small-cell Lung
- Interventions
- TAK-931
- First posted
- 2017-08-25
- Last updated
- 2021-09-20
- Results first posted
- 2021-09-20
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort | Cycle 1 (each cycle = 21 days) | DLT:Any following event related to TAK-931 assessed by Common Terminology Criteria for Adverse Events(CTCAE) version4.03;Non-febrile Grade 4 neutropenia; febrile neutropenia: Grade \>=3 neutropenia; Grade4 thrombocytopenia; Grade \>=3 thrombocytopenia of any duration accompanied by Grade 2 bleeding or requiring transfusion; delay in initiation of Cycle 2 by \>14 days due to lack of adequate recovery of treatment-related hematological or nonhematologic toxicities; Grade 2 ejection fraction decreased by echocardiogram(ECHO) or multiple gated acquisition(MUGA) scan; Grade 4 laboratory abnormalities; other Grade 2 nonhematologic toxicities considered by investigator to be related to study drug and dose-limiting; Participants receiving \<50% of doses (\<7 doses) of planned TAK-931 dosing in Cycle 1 due to study drug-related adverse events(AEs); Grade \>=3 nonhematologic toxicity with few exceptions: Grade 3 arthralgia/myalgia, fatigue, laboratory abnormalities, nausea and/or emesis or diarrhea. |
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort | From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an adverse event with an onset that occurred after receiving study drug. An SAE was any untoward medical occurrence or effect that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. |
| Primary | Disease Control Rate (DCR) in Tumor-Specific Cohorts | From first dose up to end of treatment (Up to approximately 14 months) | DCR was defined as percentage of participants documented to have unconfirmed CR, PR, or SD for at least 6 weeks from treatment initiation according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as the best response. CR was defined as disappearance of all lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of lesions, taking as reference the baseline sum LD. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD was defined as at least a 20% increase in the sum of the LD of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | |
| Secondary | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | |
| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | |
| Secondary | CLr: Renal Clearance of TAK-931 | Cycle 1 (each cycle = 21 days) Day 1 pre-dose and at multiple timepoints (up to 8 hours urine sampling) post-dose | CLr is a measure of apparent clearance of the drug from the plasma, renal clearance is a measure of drug excreted through kidneys/urine per unit time. |
| Secondary | t1/2z: Terminal Disposition Phase Half-life for TAK-931 | Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | |
| Secondary | CLss/F: Steady-state Apparent Oral Clearance for TAK-931 | Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | CL/F was defined as apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort | Cycle 1 (each cycle = 21 days) | DLT-evaluable Analysis Set included all participants in the Western Safety Cohort who received at least 1 of their planned TAK-931 doses during their first cycle of treatment (unless interrupted by related AEs) and who had sufficient follow-up data to allow the investigators and sponsor to determine whether a DLT occurred. As pre-specified in the protocol, DLTs were collected only from participants in the Western Safety Cohort who were evaluable in DLT-evaluable Analysis Set. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort | From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months) | Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure reports data only in the participants with locally advanced or metastatic solid tumors in the Western Safety Cohort. | percentage of participants | NUMBER |
| PRIMARY | Disease Control Rate (DCR) in Tumor-Specific Cohorts | From first dose up to end of treatment (Up to approximately 14 months) | Response-evaluable Analysis Set included all participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline response assessment. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts. | percentage of participants | NUMBER |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | Pharmacokinetic (PK) Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint. | ng/mL | MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint. | hour | MEDIAN |
| SECONDARY | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint. | h*ng/mL | MEAN |
| SECONDARY | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931 | Cycle 1 (each cycle = 21 days) Days 1 and 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Number analyzed is the number of participants with data available for analysis at the given timepoint. | h*ng/mL | MEAN |
| SECONDARY | CLr: Renal Clearance of TAK-931 | Cycle 1 (each cycle = 21 days) Day 1 pre-dose and at multiple timepoints (up to 8 hours urine sampling) post-dose | PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for urine PK sampling was collected only for participants in Western Safety Cohort. Overall number of participants analyzed are the number of participants with data available for analyses. | L/h | MEAN |
| SECONDARY | t1/2z: Terminal Disposition Phase Half-life for TAK-931 | Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses. | hour | MEDIAN |
| SECONDARY | CLss/F: Steady-state Apparent Oral Clearance for TAK-931 | Cycle 1 (each cycle = 21 days) Day 8 pre-dose and at multiple timepoints (up to 24 hours) post-dose | PK Analysis Set included all participants for whom there was sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameters. As prespecified in the protocol, data for intensive PK sampling was collected only for participants in Western Safety Cohort, Pancreatic Cancer Cohort, and Metastatic CRC Cohort. Overall number of participants analyzed are the number of participants with data available for analyses. | L/h | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group175
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Dose Limiting Toxicities (DLTs) in Western Safety Cohort | Western Safety Cohort | 50 | percentage of participants | ||
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort | Western Safety Cohort | TEAEs | 100 | percentage of participants | |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort | Western Safety Cohort | SAEs | 58.3 | percentage of participants | |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort | Western Safety Cohort | TEAEs Leading to Dose Modifications | 33.3 | percentage of participants | |
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading to Dose Modifications and TEAEs Leading to Treatment Discontinuation in Western Safety Cohort | Western Safety Cohort | TEAEs Leading to Treatment Discontinuation | 8.3 | percentage of participants | |
| Disease Control Rate (DCR) in Tumor-Specific Cohorts | Pancreatic Cancer Cohort | 46.2 | 26.4 to 66.9 | percentage of participants | |
| Disease Control Rate (DCR) in Tumor-Specific Cohorts | Metastatic CRC Cohort | 51.6 | 38.7 to 64.3 | percentage of participants | |
| Disease Control Rate (DCR) in Tumor-Specific Cohorts | sqEC Cohort | 52.6 | 35.8 to 69.0 | percentage of participants | |
| Disease Control Rate (DCR) in Tumor-Specific Cohorts | sqNSCLC Cohort | 58.8 | 40.6 to 75.4 | percentage of participants | |
| Cmax: Maximum Observed Plasma Concentration for TAK-931 | Western Safety Cohort | Cycle 1 Day 1 | 173.61 | Standard Deviation 59.677 | ng/mL |
1 to 10 of 175Source ClinicalTrials.gov
See all 175 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Western Safety Cohort | 12 | |
| Overall Study | STARTED | Pancreatic Cancer Cohort | 15 | |
| Overall Study | STARTED | Metastatic CRC Cohort | 35 | |
| Overall Study | STARTED | sqEC Cohort | 21 | |
| Overall Study | STARTED | sqNSCLC Cohort | 18 | |
| Overall Study | COMPLETED | Western Safety Cohort | 0 | |
| Overall Study | COMPLETED | Pancreatic Cancer Cohort | 2 | |
| Overall Study | COMPLETED | Metastatic CRC Cohort | 5 | |
| Overall Study | COMPLETED | sqEC Cohort | 0 | |
| Overall Study | COMPLETED | sqNSCLC Cohort | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events770
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Western Safety Cohort | 3 | 12 | |
| other | Nausea | Gastrointestinal disorders | Pancreatic Cancer Cohort | 5 | 15 | |
| other | Nausea | Gastrointestinal disorders | Metastatic CRC Cohort | 16 | 35 | |
| other | Nausea | Gastrointestinal disorders | sqEC Cohort | 7 | 21 | |
| other | Nausea | Gastrointestinal disorders | sqNSCLC Cohort | 7 | 18 | |
| other | Vomiting | Gastrointestinal disorders | Western Safety Cohort | 1 | 12 | |
| other | Vomiting | Gastrointestinal disorders | Pancreatic Cancer Cohort | 3 | 15 | |
| other | Vomiting | Gastrointestinal disorders | Metastatic CRC Cohort | 14 | 35 | |
| other | Vomiting | Gastrointestinal disorders | sqEC Cohort | 2 | 21 | |
| other | Vomiting | Gastrointestinal disorders | sqNSCLC Cohort | 7 | 18 |
1 to 10 of 770Source ClinicalTrials.gov
See all 770 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Western Safety Cohort | 10 | 12 |
| Total, all-cause mortality | Pancreatic Cancer Cohort | 13 | 15 |
| Total, all-cause mortality | Metastatic CRC Cohort | 17 | 35 |
| Total, all-cause mortality | sqEC Cohort | 12 | 21 |
| Total, all-cause mortality | sqNSCLC Cohort | 8 | 18 |
| Total, other adverse events | Western Safety Cohort | 5 | 12 |
| Total, other adverse events | Pancreatic Cancer Cohort | 8 | 15 |
| Total, other adverse events | Metastatic CRC Cohort | 27 | 35 |
| Total, other adverse events | sqEC Cohort | 14 | 21 |
| Total, other adverse events | sqNSCLC Cohort | 14 | 18 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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