Tivantinib and Bevacizumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01749384
Phase
PHASE1
Status
Completed

Conditions

  • Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Tivantinib — DRUG
    Given PO

Study Details

This phase I trial studies the side effects of and best dose of tivantinib when given together with bevacizumab in treating patients with solid tumors that have spread to other areas of the body or cannot be removed by surgery. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving tivantinib together with bevacizumab may work better in treating tumor cells.

Key Dates

First listed
Dec 13, 2012
Start date
Dec 6, 2012
Status verified
Oct 2017
Primary completion
May 24, 2016
Completion
May 24, 2016

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (bevacizumab, tivantinib)
    Patients receive bevacizumab IV over 30-90 minutes on days -15, 1, and 15 (day -15 of course 1 only) and tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

RP2D of the combination of tivantinib and bevacizumab, defined as the dose level at which the dose-limiting toxicity (DLT) rate is closest to 1/6 graded according to the National Cancer Institute (NCI) CTCAE v4.0 [ Time Frame: Up to 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Penn State Milton S Hershey Medical CenterHersheyPennsylvania17033-0850-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Hershey, PA

By research site
Penn State Milton S Hershey Medical Center· Hershey, PAUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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