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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: ARQ197

• Registration Number: NCT00609921
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 Phase 2 dose (RP2D) of ARQ 197.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-25
• Study First Submitted QC: 2008-01-25
• Study First Posted: 2008-02-07
• Primary Completion: 2011-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-06
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ARQ197	ARQ197

Primary Outcome Measures

Name	Time	Method
Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197

Secondary Outcome Measures

Name	Time	Method
Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile