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Completed

NCT Number: NCT00609921

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARQ197

Drug

treatment

Primary outcomes

  1. Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197

Secondary outcomes

  1. Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
First posted
Feb 7, 2008
Registry last updated
Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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