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

January 30, 2008
July 20, 2012
February 2008
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00612703 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors
A Phase 1 Dose Escalation Study of ARQ 197 Administered in Combination With Erlotinib in Adult Patients With Advanced Solid Tumors

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: ARQ 197
Treatment with ARQ 197 in combination with erlotinib
Not Provided
Goldman JW, Laux I, Chai F, Savage RE, Ferrari D, Garmey EG, Just RG, Rosen LS. Phase 1 dose-escalation trial evaluating the combination of the selective MET (mesenchymal-epithelial transition factor) inhibitor tivantinib (ARQ 197) plus erlotinib. Cancer. 2012 Dec 1;118(23):5903-11. doi: 10.1002/cncr.27575. Epub 2012 May 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
Not Provided
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00612703
ARQ 197-111
No
ArQule
ArQule
Not Provided
Principal Investigator: Lee Rosen, MD Premiere Oncology of Santa Monica
Principal Investigator: Richard G Just, MD Pacific Oncology and Hematology Associates
ArQule
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP