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NCT00609921 Clinical Trial

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

Cancer Clinical Trial

Official title:
A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00609921
Other study ID # ARQ 197-0701
Secondary ID
Status Completed
Phase Phase 1
First received January 25, 2008
Last updated September 6, 2012
Start date January 2008

Study information
Verified date September 2012
Source Kyowa Hakko Kirin Company, Limited
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ARQ197
treatment

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Kyowa Hakko Kirin Company, Limited

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197 Yes
Secondary Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile No
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