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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 Co., Ltd ( Kyowa Hakko Kirin Company, Limited ) 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 Co., Ltd:

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   (Adult, Senior)
Genders Eligible for Study:   All
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
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 identifier: NCT00609921

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

Responsible Party: Kyowa Hakko Kirin Company, Limited 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 processed this record on January 17, 2017