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

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: ARQ197

Study type: Interventional

Funder types: Industry

Identifiers

NCT00609921

ARQ 197-0701

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Active Comparator group

Description:

ARQ197

Treatment:

Drug: ARQ197