A Study of ARQ 197 in Combination With Erlotinib

NCT01251796 | Completed Phase 1

• 1 other identifier: ARQ 197-005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced/Recurrent Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetic profile of ARQ 197

  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

• Pharmacokinetic profile of Erlotinib

  At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment

• Antitumor activity

  Baseline, and then every 6 week of imaging until discontinuation criteria met

Study Arms (1)

ARQ 197 and Erlotinib

EXPERIMENTAL

ARQ 197 and erlotinib hydrochloride

Drug: ARQ 197 and Erlotinib

Interventions

ARQ 197 and Erlotinib DRUG

Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride

ARQ 197 and Erlotinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Shizuoka, Japan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ARQ 197; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 2, 2010
• Study Start: December 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

JP (1)