Status:

COMPLETED

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

Lead Sponsor:

Kyowa Kirin Co., Ltd.

Conditions:

Cancer

Eligibility:

All Genders

20+ years

Phase:

PHASE1

Brief Summary

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 Pha...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT00609921

Start Date

January 1 2008

Last Update

September 7 2012

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