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A Study of ARQ 197 in Combination With Erlotinib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01251796
First received: November 29, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Advanced/Recurrent Non-small-cell Lung Cancer
 Drug: ARQ 197 and Erlotinib
 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • Dose-Limiting Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of ARQ 197 [ Designated as safety issue: No ]
    Summary statistics of plasma concentration and pharmacokinetic parameters

  • Pharmacokinetic profile of Erlotinib [ Designated as safety issue: No ]
    Summary statistics of plasma concentration and pharmacokinetic parameters

  • Antitumor activity [ Designated as safety issue: No ]
    Response rate


Study Start Date: December 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197 and Erlotinib
ARQ 197 and erlotinib hydrochloride
 Drug: ARQ 197 and Erlotinib
Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251796

Locations
Japan
Shizuoka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01251796     History of Changes
Other Study ID Numbers: ARQ 197-005
Study First Received: November 29, 2010
Last Updated: March 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013