Brief Title
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Official Title
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Brief Summary
This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer. The purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Secondary Outcome
Overall Response Rate (ORR) - Phase I
Condition
Non-small Cell Lung Cancer
Intervention
CT-707
Study Arms / Comparison Groups
CT-707
Description: ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
March 2016
Completion Date
March 2018
Primary Completion Date
March 2018
Eligibility Criteria
Inclusion Criteria: Patients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally. Eastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1 Availability of tumor sample: Exclusion Criteria: Patients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease. Other protocol-defined inclusion/exclusion criteria may apply.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Yuankai Shi, Dr, 86(10)88858866, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02695550
Organization ID
CT-707-101
Responsible Party
Sponsor
Study Sponsor
Centaurus Biopharma Co., Ltd.
Study Sponsor
Yuankai Shi, Dr, Principal Investigator, Cancer Hospital of Chines Academy of Medical Sciences
Verification Date
March 2017