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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00609921

Enrollment

Registered

2008-02-07

Start date

2008-01-31

Completion date

Unknown

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGARQ197

treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197	—

Secondary

Measure	Time frame
Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026