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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612703
First Posted: February 12, 2008
Last Update Posted: July 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ArQule
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 30, 2008
First Posted: February 12, 2008
Last Update Posted: July 23, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action