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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ArQule
ClinicalTrials.gov Identifier:
NCT00612703
First received: January 30, 2008
Last updated: July 20, 2012
Last verified: July 2012
  Purpose

To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors


Condition Intervention Phase
Cancer
Drug: ARQ 197
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 197 Administered in Combination With Erlotinib 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 recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the pharmacokinetic profiles of ARQ 197 and erlotinib, when administered in combination to patients with advanced solid tumors [ Time Frame: No time frame ] [ Designated as safety issue: No ]
  • To assess the preliminary anti-tumor activity of ARQ 197 when administered in combination with erlotinib to adult patients with advanced solid tumors [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: February 2008
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ARQ 197
    Treatment with ARQ 197 in combination with erlotinib
  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 according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
  • A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate
  • ≥ 18 years of age
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)
  • Major surgery within 4 weeks prior to first dose
  • Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
  • Pregnant or breastfeeding
  • Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612703

Locations
United States, California
San Diego Pacific Oncology and Hematology Associates Inc.
Encinitas, California, United States, 92024
Premiere Oncology
Santa Monica, California, United States, 90404
Sponsors and Collaborators
ArQule
Investigators
Principal Investigator: Lee Rosen, MD Premiere Oncology of Santa Monica
Principal Investigator: Richard G Just, MD Pacific Oncology and Hematology Associates
  More Information

No publications provided by ArQule

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ArQule
ClinicalTrials.gov Identifier: NCT00612703     History of Changes
Other Study ID Numbers: ARQ 197-111
Study First Received: January 30, 2008
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
Cancer, oral, erlotinib, tarceva, solid tumor, advanced tumor, phase 1
Tumor

Additional relevant MeSH terms:
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014