A Study of ARQ 197 in Combination With Erlotinib

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01069757
• Other study ID #: ARQ 197-003
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2010
• Last updated: March 14, 2017
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2017
• Source: Kyowa Hakko Kirin Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer

Intervention

Drug:
• ARQ 197 and Erlotinib
Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome

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