Solid Tumor
Phase Ib Study of the Combination of Pazopanib, an Oral VEGFR Inhibitor, and ARQ 197 (Tivantinib), an Oral MET Inhibitor, in Patients With Refractory Advanced Solid Tumors
NCI-12-C-0009, NCT01468922
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Investigator(s): |
Shivaani Kummar, M.D., F.A.C.P.
Principal Investigator
Phone: 301-435-0517
Fax: 301-496-0826
kummars@mail.nih.gov
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Janelle Bingham, R.N.
Referral Coordinator
Phone: 301-435-2715
Fax: 301-451-5433
jbingham@mail.nih.gov
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Lemual Clayborn
Referral Coordinator
Phone: 301-451-0992
Fax: 301-496-0826
claybornlr@mail.nih.gov
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Ramya Parthasarathy, B.S.N., R.N., O.C.N.
Research Nurse
Phone: 301-594-4949
Fax: 301-480-7281
parthasarathyr@mail.nih.gov
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Key Eligibility Criteria:
- Histologically confirmed diagnosis of a solid tumor (participants enrolling in the expansion phase must have histologically confirmed sarcomas, gastric cancer, or total c-MET-expressing malignancies)
- Failed at least one line of prior therapy or have a disease for which no standard curative therapy exists
- Measurable or evaluable disease
- ECOG of 0-1
- Adequate organ and bone marrow function
- Able to swallow whole tablets or capsules
- No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
- No therapy within 4 weeks prior to entry of study
- Patients enrolling in expansion phase must have disease amenable to biopsy and be willing to undergo pre- and post- treatment biopsies
Study Outline:
- Screening physical examination; blood and tumor samples; and imaging studies to determine eligibility for the study
- Pazopanib once a day and ARQ 197 twice a day by mouth every day, in 4-week cycles
- Some participants will start with pazopanib or ARQ 197 alone for the first week; then they will take both drugs together for the rest of the study
- Cycles continue for as long as there is no progressive disease or unacceptable toxicity
- Participants will be monitored with blood samples, physical examinations, and tumor imaging studies through the cycles of treatment
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 9/12/12
Updated: 9/20/12
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