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A Study of ARQ 197 in Combination With Erlotinib

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ClinicalTrials.gov Identifier: NCT01251796
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

November 29, 2010
December 2, 2010
March 15, 2017
December 2010
November 2012   (Final data collection date for primary outcome measure)
Dose-Limiting Toxicity in the combination of tivantinib and erlotinib [ 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. ]
Tivantinib was treated once as a single agent on Day 1. After 2 days of interruption, dayly treatments of the combination started.
Dose-Limiting Toxicity
Complete list of historical versions of study NCT01251796 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile of ARQ 197 [ 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 ]
    Summary statistics of plasma concentration and pharmacokinetic parameters
  • Pharmacokinetic profile of Erlotinib [ Time Frame: At pre-dose, 1, 2, 4, 6, 10, 12 hours on the day of the first comnibation treatment ]
    Summary statistics of plasma concentration and pharmacokinetic parameters
  • Antitumor activity [ Time Frame: Baseline, and then every 6 week of imaging until discontinuation criteria met ]
    Response rate
  • 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
Not Provided
Not Provided
 
A Study of ARQ 197 in Combination With Erlotinib
A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Advanced/Recurrent Non-small-cell Lung Cancer
Drug: ARQ 197 and Erlotinib
Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride
Experimental: ARQ 197 and Erlotinib
ARQ 197 and erlotinib hydrochloride
Intervention: Drug: ARQ 197 and Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
Not Provided
November 2012
November 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01251796
ARQ 197-005
Not Provided
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP