Non-small-cell Lung Cancer Clinical Trial
Official title:
A Phase I Study of ARQ 197 in Combination With Erlotinib in Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
Verified date | March 2017 |
Source | Kyowa Hakko Kirin Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 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.
Status | Completed |
Enrollment | 16 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kyowa Hakko Kirin Co., Ltd |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | DLT observation period started from the day of first single agent treatment to the day after the continuous combination treatment for 29 days. | |
Secondary | Plasma concentration and pharmacokinetic parameters of ARQ 197 and Erlotinib | Plasma concentration of tivantinib was measured on both Day 1 and the first day of the combination. Plasma concentration of erlotinib was also measured on the first day of the combination. | Plasma sample correction at pre-dose, 1, 2, 4, 6, 10, 12 and 24 hours on Day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment | |
Secondary | Antitumor activity | Baseline, and then every 6 week of imaging until discontinuation criteria met |
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