Study of ARQ 197 Monotherapy (ARQ 197-004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01152645
First received: June 25, 2010
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

A phase II open-label study with ARQ 197 administered orally and twice daily as monotherapy in patients with previously treated advanced/recurrent gastric cancer. The primary endpoint is disease control and the secondary efficacy endpoints include antitumor effect (tumor response), progression-free survival and overall survival. The pharmacokinetic profile and the safety profile are also evaluated.


Condition Intervention Phase
Gastric Cancer
Drug: ARQ 197
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ARQ 197 Monotherapy for Previously Treated Advanced/Recurrent Gastric Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Antitumor effect [ Designated as safety issue: No ]
    Disease control


Secondary Outcome Measures:
  • Antitumor effect [ Designated as safety issue: No ]
    Tumor response

  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Pharmacokinetic profile [ Designated as safety issue: No ]
    Plasma ARQ 197 concentrations and pharmacokinetic parameters following the first dose of ARQ 197

  • Adverse events [ Designated as safety issue: Yes ]

Study Start Date: June 2010
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARQ 197 Drug: ARQ 197
Orally twice daily administration of ARQ 197

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese or Korean with voluntary written informed consent for study participation
  • A histologically or cytologically confirmed advanced/recurrent gastric cancer
  • One or two prior chemotherapy regimens for advanced/recurrent gastric cancer
  • At least one measurable lesion
  • ECOG performance status of 0 or 1
  • Life expectancy ≥3 months

Exclusion Criteria:

  • Surgery for cancer within 4 weeks prior to the first dose of ARQ 197
  • Confirmed other tumors than gastric cancer within 5 years prior to the first dose of ARQ 197
  • Anticancer chemotherapy, hormone therapy, radiotherapy or immunotherapy within 2 weeks prior to the first dose of ARQ 197
  • Positive for HIV antibody
  • Known symptomatic brain metastasis
  • Gastrointestinal disorders that could interfere with the absorption of ARQ 197 or operation history for gastrointestinal disorders
  • Uncontrolled concomitant disease
  • Patients who wish to have a child and who would not agree to use contraceptive measures
  • Pregnant or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01152645

Locations
Japan
Nagoya, Japan
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01152645     History of Changes
Other Study ID Numbers: ARQ 197-004
Study First Received: June 25, 2010
Last Updated: September 6, 2012
Health Authority: Korea: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Advanced/recurrent gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 16, 2014