A Study of ARQ 171 in Patients With Advanced Solid Tumors

This study has suspended participant recruitment.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00398840
First received: November 9, 2006
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly.

Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.


Condition Intervention Phase
Cancer
Drug: ARQ 171
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by ArQule:

Primary Outcome Measures:
  • To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171

Secondary Outcome Measures:
  • To determine the pharmacokinetic profile of ARQ 171
  • To assess the preliminary anti-tumor activity of ARQ 171

Estimated Enrollment: 30
Study Start Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent must be obtained and documented prior to study-specific screening procedures.
  • A histologically or cytologically confirmed advanced solid tumor
  • ≥ 18 years of age
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
  • Karnofsky performance status ≥ 70%
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after participation.
  • Females of childbearing potential must have a negative serum pregnancy test.
  • Laboratory results must meet study criteria.

Exclusion Criteria:

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion
  • Surgery within 4 weeks prior to first infusion
  • Known untreated brain metastases
  • Pregnant or breastfeeding
  • Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
  • Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398840

Locations
United States, California
Premiere Oncology
Santa Monica, California, United States, 85260
United States, Massachusetts
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02115
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75201
Sponsors and Collaborators
ArQule
  More Information

No publications provided

Responsible Party: Arqule, Arqule, Inc.
ClinicalTrials.gov Identifier: NCT00398840     History of Changes
Other Study ID Numbers: ARQ 171-101
Study First Received: November 9, 2006
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
Cancer
Solid Tumors
advanced solid tumors

ClinicalTrials.gov processed this record on July 31, 2014