NCT00609921

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

3.7 years

First QC Date

January 25, 2008

Last Update Submit

September 6, 2012

Conditions

Cancer

Outcome Measures

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

Study Arms (1)

1

ACTIVE COMPARATOR

ARQ197

Drug: ARQ197

Interventions

ARQ197DRUG

treatment

1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

ARQ 197

Study Officials

  • Study Director

    Kyowa Kirin Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 7, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2011

Last Updated

September 7, 2012

Record last verified: 2012-09