A Study to Evaluate TAK-931 in Participants With Advanced Nonhematologic Tumors
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|ClinicalTrials.gov Identifier: NCT02699749|
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Nonhematologic Neoplasms, Advanced||Drug: TAK-931||Phase 1|
The drug being under investigation in this study is called TAK-931. The effect of TAK-931 is being evaluated in up to 100 participants who have nonhematologic (solid) neoplasms. This study will look at the safety, tolerability, and PK to determine the maximum tolerated dose (MTD) of TAK-931.
This multi-center trial will be conducted in Japan. The overall study duration is approximately 42 months for total of dose escalation cohorts and the safety expansion cohort. Participants will make multiple visits to the clinic with final visit approximately 30-40 days after last dose of study drug for a follow-up assessment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-931, a Cell Division Cycle 7 (CDC7) Inhibitor, in Adult Patients With Advanced Nonhematologic Tumors|
|Actual Study Start Date :||March 24, 2016|
|Actual Primary Completion Date :||December 21, 2019|
|Actual Study Completion Date :||December 21, 2019|
TAK-931 30 mg, capsules, orally, QD or BID on Days 1-14 of each 21-day treatment cycle in dosing schedule A followed by dosing schedule B, C, D, E and F. In dosing schedules B through F, starting doses and dosing escalations will vary depending on the dosing data obtained from dosing in the previous schedule.
Dose escalation of TAK-931 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data. 3-4 dose cohorts are expected for each dosing schedule.
If the PK from the early cohorts support BID dosing, then study drug administration in subsequent cohorts may transition to a BID dosing schedule.
TAK-931 oral capsules.
- Number and Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Toxicity will be assessed in the first cycle of dosing up to dosing on Cycle 2 Day 1 ]DLTs are any of the events specified in the protocol that are considered by the investigator to be at least possibly related to study drug. DLTs will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
- Number and Percentage of Participants Reporting Adverse Events (AEs) [ Time Frame: Baseline up to 30-40 days after the last dose of study drug (with last dose at approximately 3 months) ]
- Cmax: Maximum Observed Plasma Concentration for TAK-931 [ Time Frame: Concentrations will be assessed at multiple time points (up to 24 hours postdose ) on Cycle 1 (Days 1 and 7 or Days 1 and 8) ]
- Tmax: Time to Reach the Maximum Plasma Concentration for TAK-931 [ Time Frame: Cycle 1: Days 1 and 7 or Days 1 and 8: at multiple time points (up to 24 hours postdose) ]
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-931 Once Daily (QD) Dosing [ Time Frame: Cycle 1: Days 1 and 7 or Days 1 and 8: at multiple time points (up to 24 hours post dose) ]
- AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Postdose for TAK-931 Twice Daily (BID) Dosing [ Time Frame: Cycle 1: Days 1 and 7 or Days 1 and 8: at multiple time points (up to 24 hours post dose) ]
- AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-931 [ Time Frame: Cycle 1: Days 1 and 7 or Days 1 and 8: at multiple time points (up to 24 hours postdose) ]
- Change from Baseline in Phosphorylated Minichromosome Maintenance Complex-2 (pMCM2) (Ser40) Levels in Skin [ Time Frame: Skin biopsies will be collected at screening or Cycle 1 Day 1 pre-dose and on any dosing day after 3 consecutive days post-dose ]
- Overall Response Rate (ORR) [ Time Frame: From the first dose until complete response [CR] or partial response [PR] as assessed at Cycle 4 Day 1, and then every 3 cycles thereafter through the study completion (approximately 3 months) ]
- Progression-free Survival (PFS) [ Time Frame: From the first dose until disease progression or death (approximately 3 months) ]
- Duration of Response (DOR) [ Time Frame: Time from participant's initial CR or PR to the time of disease progression (approximately 3 months) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699749
|Kashiwa, Chiba, Japan|
|Chuo-ku, Tokyo, Japan|
|Study Director:||Study Director||Takeda|