- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695550
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Yong Peng, Dr.
- Phone Number: 86(10)88858866
- Email: ypeng@centaurusbio.com
Study Locations
-
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Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital of Chinese Academy of Medical Sciences
-
Contact:
- Yuankai Shi, M.D.
- Phone Number: 86(10)67781331
- Email: syuankaipumc@126.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CT-707
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
Time Frame: 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
|
28 days
|
Frequency of adverse events/serious adverse events
Time Frame: Up to 24 months
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Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) - Phase I
Time Frame: Up to 24 month
|
Preliminary measure of anti-tumor activity of CT-707
|
Up to 24 month
|
Progression free survival (PFS) per RECIST v1.1 - Phase I
Time Frame: Up to 24 months
|
Preliminary measures of anti-tumor activity of CT-707
|
Up to 24 months
|
Duration of response (DOR)
Time Frame: Up to 24 months
|
Preliminary measure of anti-tumor activity of CT-707
|
Up to 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yuankai Shi, Dr, Cancer Hospital of Chines Academy of Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Conteltinib
Other Study ID Numbers
- CT-707-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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