Trial · NCT02699749
A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors
NCT02699749, Phase 1, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors. Trials, record NCT02699749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02699749
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors
- NCT number
- NCT02699749
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 80 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Nonhematologic Neoplasms, Advanced
- Interventions
- TAK-931
- First posted
- 2016-03-04
- Last updated
- 2021-02-21
- Results first posted
- 2021-02-21
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Baseline up to Cycle 1 (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | Toxicity was evaluated by NCI CTCAE v4.03. DLT:any of following occurred events during Cycle 1 considered by investigator to be possibly related to therapy:1)Grade4 neutropenia,2)Febrile neutropenia lasting greater(\>)1 hour,3)Grade greater than or equal to (\>=)3 neutropenia with infection,4)Grade \>=3 thrombocytopenia with bleeding,4)Grade 4 thrombocytopenia,5)delay in initiation of Cycle 2 by \>14 days,6)Grade 2:\<Grade 2 ejection fraction,7)other Grade 2 nonhematologic toxicities considered by investigator related to study drug and DLTs,8)who received \<50 percent of doses of planned TAK-931 dosing in Cycle 1 for related AEs:\<7 QD/\<14 BID doses (Schedules A,B);\<11 QD/\<21 BID doses(Schedule D),\<3 QD/\<6 BID doses for(Schedule E),9)Grade \>=3 nonhematologic toxicity except arthralgia/myalgia and fatigue, isolated \>=Grade 3 laboratory abnormalities if it is asymptomatic and resolves to \<=Grade 1 or baseline levels in \<=7 days;inadequately treated Grade 3 nausea and/or vomiting and diarrhea. |
| Primary | Number of Participants With Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (up to Day 499) | |
| Secondary | Cmax: Maximum Observed Plasma Concentration After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | AUC12: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours After Multiple Doses of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-931 | Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After Multiple Doses of TAK-931 | Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | |
| Secondary | AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours After Multiple Doses of TAK-931 | Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Baseline up to Cycle 1 (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The DLT-evaluable population was defined as all participants who received at least 75% of their planned TAK-931 doses for their first cycle of treatment (unless interrupted by study drug-related AEs) and who had sufficient follow-up data to allow the investigators and sponsor to determine whether DLT occurred. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 30 days after the last dose of study drug or before initiation of new anti-cancer therapy (up to Day 499) | The safety population was defined as all participants who received any amount of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The pharmacokinetic (PK) population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | hours | MEDIAN |
| SECONDARY | AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | hour*nanogram per milliliter (h*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | AUC12: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours After Multiple Doses of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8 and 12 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration After First Dose of TAK-931 | Cycle 1 Day 1: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-931 | Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After Multiple Doses of TAK-931 | Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | hours | MEDIAN |
| SECONDARY | AUC24: Area Under the Plasma Concentration-time Curve From 0 to 24 Hours After Multiple Doses of TAK-931 | Cycle 1 Day 8 (Schedule A and D), Cycle 1 Day 7 (Schedule B), Cycle 1 Day 9 (Schedule E): pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hours post-dose (Cycle length= 21 days [Schedules A, D and E] and 28 days [Schedule B]) | The PK population was defined as all participants for whom there were sufficient dosing and TAK-931 concentration-time data to reliably estimate the PK parameter(s). Here overall number of participants analyzed are participants who were available for this outcome measure assessment at given time period. | h*ng/mL | GEOMETRIC_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group221
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule A: TAK-931 30 mg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule A: TAK-931 40 mg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule A: TAK-931 50 mg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule A: TAK-931 60 mg | 2 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule B: TAK-931 60 mg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule B: TAK-931 80 mg | 2 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule B: TAK-931 100 mg | 1 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule B: TAK-931 120 mg | 1 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule D: TAK-931 20 mg | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) Assessed by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Version 4.03 | Schedule D: TAK-931 30 mg | 0 | Participants |
1 to 10 of 221Source ClinicalTrials.gov
See all 221 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Schedule A: TAK-931 30 mg | 3 | |
| Overall Study | STARTED | Schedule A: TAK-931 40 mg | 3 | |
| Overall Study | STARTED | Schedule A: TAK-931 50 mg | 16 | |
| Overall Study | STARTED | Schedule A: TAK-931 60 mg | 3 | |
| Overall Study | STARTED | Schedule B: TAK-931 60 mg | 3 | |
| Overall Study | STARTED | Schedule B: TAK-931 80 mg | 9 | |
| Overall Study | STARTED | Schedule B: TAK-931 100 mg | 6 | |
| Overall Study | STARTED | Schedule B: TAK-931 120 mg | 6 | |
| Overall Study | STARTED | Schedule D: TAK-931 20 mg | 6 | |
| Overall Study | STARTED | Schedule D: TAK-931 30 mg | 6 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events2,394
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 | Schedule A: TAK-931 30 mg | 0 | 3 | |
| other | Nausea | Gastrointestinal disorders | Schedule A: TAK-931 40 mg | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | Schedule A: TAK-931 50 mg | 10 | 16 | |
| other | Nausea | Gastrointestinal disorders | Schedule A: TAK-931 60 mg | 3 | 3 | |
| other | Nausea | Gastrointestinal disorders | Schedule B: TAK-931 60 mg | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | Schedule B: TAK-931 80 mg | 9 | 9 | |
| other | Nausea | Gastrointestinal disorders | Schedule B: TAK-931 100 mg | 5 | 6 | |
| other | Nausea | Gastrointestinal disorders | Schedule B: TAK-931 120 mg | 6 | 6 | |
| other | Nausea | Gastrointestinal disorders | Schedule D: TAK-931 20 mg | 0 | 6 | |
| other | Nausea | Gastrointestinal disorders | Schedule D: TAK-931 30 mg | 3 | 6 |
1 to 10 of 2,394Source ClinicalTrials.gov
See all 2,394 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Schedule A: TAK-931 30 mg | 0 | 3 |
| Total, all-cause mortality | Schedule A: TAK-931 40 mg | 0 | 3 |
| Total, all-cause mortality | Schedule A: TAK-931 50 mg | 0 | 16 |
| Total, all-cause mortality | Schedule A: TAK-931 60 mg | 0 | 3 |
| Total, all-cause mortality | Schedule B: TAK-931 60 mg | 0 | 3 |
| Total, all-cause mortality | Schedule B: TAK-931 80 mg | 0 | 9 |
| Total, all-cause mortality | Schedule B: TAK-931 100 mg | 0 | 6 |
| Total, all-cause mortality | Schedule B: TAK-931 120 mg | 0 | 6 |
| Total, all-cause mortality | Schedule D: TAK-931 20 mg | 0 | 6 |
| Total, all-cause mortality | Schedule D: TAK-931 30 mg | 0 | 6 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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