Advanced/Recurrent Non-small-cell Lung Cancer Clinical Trial
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
| 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 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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| 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 - 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 |
| 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 | Pharmacokinetic profile of ARQ 197 | Summary statistics of plasma concentration and pharmacokinetic parameters | 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 | |
| Secondary | Pharmacokinetic profile of Erlotinib | Summary statistics of plasma concentration and pharmacokinetic parameters | At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment | |
| Secondary | Antitumor activity | Response rate | Baseline, and then every 6 week of imaging until discontinuation criteria met |