Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
- Registration Number
- NCT02695550
- Lead Sponsor
- Centaurus Biopharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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:
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CT-707 CT-707 ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
- Primary Outcome Measures
Name Time Method Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) 28 days Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days
Frequency of adverse events/serious adverse events Up to 24 months Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) - Phase I Up to 24 month Preliminary measure of anti-tumor activity of CT-707
Progression free survival (PFS) per RECIST v1.1 - Phase I Up to 24 months Preliminary measures of anti-tumor activity of CT-707
Duration of response (DOR) Up to 24 months Preliminary measure of anti-tumor activity of CT-707
Trial Locations
- Locations (1)
Cancer Hospital of Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China