Back to resultsA Study of ARQ 197 in Combination With Erlotinib
Primary Purpose
Advanced/Recurrent Non-small-cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ARQ 197 and Erlotinib
Sponsored by
About this trial
This is an interventional treatment trial for Advanced/Recurrent Non-small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Voluntary written informed consent for study participation must be obtained
- A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
- History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
- ECOG PS of 0 or 1
- Life expectancy of ≥3 months
- Poor metabolizers as defined by CYP2C19 genotype
Exclusion Criteria:
- Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
- Surgery for cancer within 28 days prior to ARQ 197 dose
- Active double cancer
- Known symptomatic brain metastases
- An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
- Pregnant or lactating
- Subjects who wish to have a child and who would not agree to use contraceptive measures
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARQ 197 and Erlotinib
Arm Description
ARQ 197 and erlotinib hydrochloride
Outcomes
Primary Outcome Measures
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Secondary Outcome Measures
Pharmacokinetic profile of ARQ 197
Summary statistics of plasma concentration and pharmacokinetic parameters
Pharmacokinetic profile of Erlotinib
Summary statistics of plasma concentration and pharmacokinetic parameters
Antitumor activity
Response rate
Full Information
NCT ID
NCT01251796
First Posted
November 29, 2010
Last Updated
March 14, 2017
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01251796
Brief Title
A Study of ARQ 197 in Combination With Erlotinib
Official Title
A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This is a phase I study to determine the safety, tolerability and recommended phase II dose of ARQ 197 given in combination with erlotinib as primary endpoints in CYP2C19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. The pharmacokinetic profile and antitumor activity of ARQ 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced/Recurrent Non-small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARQ 197 and Erlotinib
Arm Type
Experimental
Arm Description
ARQ 197 and erlotinib hydrochloride
Intervention Type
Drug
Intervention Name(s)
ARQ 197 and Erlotinib
Intervention Description
Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride
Primary Outcome Measure Information:
Title
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib
Description
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Time Frame
DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days.
Secondary Outcome Measure Information:
Title
Pharmacokinetic profile of ARQ 197
Description
Summary statistics of plasma concentration and pharmacokinetic parameters
Time Frame
Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1, and in addition, at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Title
Pharmacokinetic profile of Erlotinib
Description
Summary statistics of plasma concentration and pharmacokinetic parameters
Time Frame
At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment
Title
Antitumor activity
Description
Response rate
Time Frame
Baseline, and then every 6 week of imaging until discontinuation criteria met
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntary written informed consent for study participation must be obtained
A histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer
History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase inhibitors will be counted as one regimen)
ECOG PS of 0 or 1
Life expectancy of ≥3 months
Poor metabolizers as defined by CYP2C19 genotype
Exclusion Criteria:
Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to ARQ 197 dose
Surgery for cancer within 28 days prior to ARQ 197 dose
Active double cancer
Known symptomatic brain metastases
An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia)
Pregnant or lactating
Subjects who wish to have a child and who would not agree to use contraceptive measures
Facility Information:
City
Shizuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of ARQ 197 in Combination With Erlotinib
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