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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014