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

September 6, 2012 updated by: Kyowa Kirin Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
ARQ197
Drug: ARQ197
treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Assess the preliminary anti-tumor activity and determine the pharmacokinetic profile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (ESTIMATE)

February 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • ARQ 197-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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