Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02279433
Study type Interventional
Source AnHeart Therapeutics Inc.
Contact
Status Completed
Phase Phase 1
Start date September 2014
Completion date March 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT00750841 - Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours Phase 1
Withdrawn NCT05419817 - Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System Phase 2
Completed NCT02828930 - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) Phase 1
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Terminated NCT03225105 - M3541 in Combination With Radiotherapy in Solid Tumors Phase 1
Completed NCT03258515 - A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers Phase 1
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT03634982 - Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors Phase 1
Recruiting NCT04685226 - A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT06036121 - A Study of ADRX-0706 in Select Advanced Solid Tumors Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT01528046 - Metformin in Children With Relapsed or Refractory Solid Tumors Phase 1
Recruiting NCT05325866 - A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Phase 1/Phase 2
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Withdrawn NCT01940601 - Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors Phase 2