Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CT-707-101
- NCT ID:
NCT02695550
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
CT-707 | | CT-707 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CT-707 | Experimental | ALK-positive non-small cell lung cancer resistant to Crizotinib treatment | |
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.
Maximum Eligible Age: | 65 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) |
Time Frame: | 28 days |
Safety Issue: | |
Description: | 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 |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) - Phase I |
Time Frame: | Up to 24 month |
Safety Issue: | |
Description: | Preliminary measure of anti-tumor activity of CT-707 |
Measure: | Progression free survival (PFS) per RECIST v1.1 - Phase I |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Preliminary measures of anti-tumor activity of CT-707 |
Measure: | Duration of response (DOR) |
Time Frame: | Up to 24 months |
Safety Issue: | |
Description: | Preliminary measure of anti-tumor activity of CT-707 |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | Centaurus Biopharma Co., Ltd. |
Last Updated
March 9, 2017