A Phase 1 Study of ARQ 197 in Patients With Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
First received: January 25, 2008
Last updated: September 6, 2012
Last verified: September 2012

This is a Phase 1, open label, dose escalation study of ARQ 197 in patients with advanced/recurrent solid tumors. The purpose of this study is to determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197.

Condition Intervention Phase
Drug: ARQ197
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: January 2008
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: ARQ197


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

Inclusion Criteria:

  • Patients who did not respond or are refractory to available therapy or for whom no standard effective systemic therapy exists.
  • Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Patients with adequate organ function

Exclusion Criteria:

  • Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of ARQ 197
  • Known symptomatic brain metastases
  • Pregnant or breastfeeding
  • Uncontrolled intercurrent illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609921

Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00609921     History of Changes
Other Study ID Numbers: ARQ 197-0701
Study First Received: January 25, 2008
Last Updated: September 6, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on April 17, 2014