Back to resultsStudy of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CT-707
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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.
Sites / Locations
- Cancer Hospital of Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CT-707
Arm Description
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
Outcomes
Primary Outcome Measures
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
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
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
Secondary Outcome Measures
Overall Response Rate (ORR) - Phase I
Preliminary measure of anti-tumor activity of CT-707
Progression free survival (PFS) per RECIST v1.1 - Phase I
Preliminary measures of anti-tumor activity of CT-707
Duration of response (DOR)
Preliminary measure of anti-tumor activity of CT-707
Full Information
NCT ID
NCT02695550
First Posted
February 23, 2016
Last Updated
March 8, 2017
Sponsor
Centaurus Biopharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02695550
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centaurus Biopharma Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CT-707
Arm Type
Experimental
Arm Description
ALK-positive non-small cell lung cancer resistant to Crizotinib treatment
Intervention Type
Drug
Intervention Name(s)
CT-707
Primary Outcome Measure Information:
Title
Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
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
Time Frame
28 days
Title
Frequency of adverse events/serious adverse events
Description
Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR) - Phase I
Description
Preliminary measure of anti-tumor activity of CT-707
Time Frame
Up to 24 month
Title
Progression free survival (PFS) per RECIST v1.1 - Phase I
Description
Preliminary measures of anti-tumor activity of CT-707
Time Frame
Up to 24 months
Title
Duration of response (DOR)
Description
Preliminary measure of anti-tumor activity of CT-707
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Peng, Dr.
Phone
86(10)88858866
Email
ypeng@centaurusbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, Dr
Organizational Affiliation
Cancer Hospital of Chines Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital of Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi, M.D.
Phone
86(10)67781331
Email
syuankaipumc@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30381078
Citation
Liang C, Zhang N, Tan Q, Liu S, Luo R, Wang Y, Shi Y, Han X. CT-707 Overcomes Resistance of Crizotinib through Activating PDPK1- AKT1 Pathway by Targeting FAK. Curr Cancer Drug Targets. 2019;19(8):655-665. doi: 10.2174/1568009618666181031152140.
Results Reference
derived
Learn more about this trial
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
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