A Phase 1/1B Multi-Center, Non Randomized, Open-Label, Multiple Dose First-In-Human Study Of DS-6051b, An Oral ROS1 And NTRK Inhibitor, In Subjects With Metastatic and/or Unresectable Solid Tumors
Sponsor study identifier
interventional
46
1 country
6
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2019
Actual (reported)Study Completion
March 2019
Actual (reported)DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 15, 2014
Actual (reported)October 31, 2014
Actual (reported)March 2019
Actual (reported)March 2019
Actual (reported)Part 1: Number of participants with dose-limiting toxicities
within 21 days following the first dose of treatment
Tumor response
Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
up to 2 years
Maximum concentration (Cmax) for DS-6051a
At Days 1 and 15 of Cycle 1 (21 days)
Time to maximum concentration (Tmax) for DS-6051a
At Days 1 and 15 of Cycle 1 (21 days)
Area under the concentration-time curve from time zero to t (AUC0-t) for DS-6051a
At Days 1 and 15 of Cycle 1 (21 days)
Change from baseline in QTc interval
within 2 years
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Chao Family Comprehensive Cancer Center of
Orange, California, 92868, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Inst.
Boston, Massachusetts, 02215, United States
New York University
New York, New York, 10016, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
Study Director Oncology
AnHeart Therapeutics Inc.
46 participants (actual enrollment reported by the registry).
First Submitted
October 15, 2014
First Posted
October 31, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors
Contact the study team to confirm eligibility.
Primary Completion
March 2019
Actual (reported)Study Completion
March 2019
Actual (reported)Last Updated
June 24, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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