A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b
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|ClinicalTrials.gov Identifier: NCT02279433|
Recruitment Status : Active, not recruiting
First Posted : October 31, 2014
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: DS6051b||Phase 1|
The Dose Escalation part (Part 1) of this study will evaluate safety and tolerability, and determine the tentative RP2D. Plasma exposure of DS-6051a and the exposure - QT interval prolongation relationship will also be assessed. Approximately 30 subjects with advanced solid tumors harboring ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement, neuroendocrine carcinoma, or with advanced solid tumors and tumor-induced pain will be enrolled.
The Food Effect (FE) part of this study is to determine the effect of food on the PK of DS-6051a following administration of a single oral dose of DS-6051b. The safety and tolerability of DS-6051b administered with or without food will also be assessed.
After the safety profile of DS-6051b is adequately evaluated, the Dose Expansion part (Part 2) will be initiated to further assess the safety and tolerability, and preliminarily evaluate the efficacy of DS-6051b at the tentative RP2D. Approximately 40 cancer subjects carrying a ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Two-Part, Multi-Center, Non Randomized, Open-Label, Multiple Dose First-In-Human Study Of DS-6051b, An Oral ROS1 And NTRK Inhibitor, In Subjects With Advanced Solid Tumors|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
DS-6051b is orally administered as 50 mg and 200 mg capsules once daily on Days 1 to 21 of a 21-day cycle. Dose escalation in Part 1 will continue until tentative Recommended Part 2 Dose (RP2D) is determined. In Part 2 participants will receive the RP2D.
DS-6051b 50 mg and 200 mg capsules for oral administration
- Part 1: Number of participants with dose-limiting toxicities [ Time Frame: within 21 days following the first dose of treatment ]
- Part 2: Tumor response [ Time Frame: up to 2 years ]Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Maximum concentration (Cmax) for DS-6051a [ Time Frame: At Days 1 and 15 of Cycle 1 ]
- Time to maximum concentration (Tmax) for DS-6051a [ Time Frame: At Days 1 and 15 of Cycle 1 ]
- Area under the concentration-time curve from time zero to t (AUC0-t) for DS-6051a [ Time Frame: At Days 1 and 15 of Cycle 1 ]
- Change from baseline in QTc interval [ Time Frame: within 2 years ]ECGs performed to assess QTc interval (ms) at baseline and on study treatment and at the end of treatment visit.
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): NCT02279433
|United States, Arizona|
|HonorHealth Research Institute|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Chao Family Comprehensive Cancer Center of|
|Orange, California, United States, 92868|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana Farber Cancer Inst.|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|New York University|
|New York, New York, United States, 10016|
|United States, Texas|
|South Texas Accelerated Research Therapeutics|
|San Antonio, Texas, United States, 78229|
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|