Last updated on November 2016

Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors


Brief description of study

CK-101 is a novel, potent, small molecule tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral CK-101; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral CK-101; to assess the safety and efficacy of CK-101 in previously treated NSCLC patients known to have the T790M EGFR mutation.

Detailed Study Description

This is a first-in-human, two-part, open-label, safety, pharmacokinetic, and efficacy study of oral CK-101 administered daily in ascending doses in patients with advanced solid tumor cancer, followed by a Phase 2 portion at the recommended Phase 2 dose (RP2D) in previously treated non-small cell lung cancer (NSCLC) patients who have documented evidence of EGFR T790M mutation and have failed treatment with a first-line EGFR inhibitor.

Clinical Study Identifier: NCT02926768

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Sarah Cannon Research Institute

Research Site
Sarasota, FL United States
  Connect »

Sarah Cannon Research Institute

Research Site
Norman, OK United States
  Connect »

Sarah Cannon Research Institute

Research Site
Nashville, TN United States
  Connect »