Study of Nintedanib Plus Bevacizumab in Advanced Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT02835833
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nintedanib — DRUG
    Nintedanib will be given twice daily at either 150 mg or 200 mg.
  • Bevacizumab — DRUG
    Bevacizumab will be given at 15 mg/kg

Study Details

Angiogenesis, the development of new blood vessels, plays an important role in the disease development and tumor growth in many solid organ malignancies. Bevacizumab was the first anti-angiogenic drug to be approved in solid tumors and has shown advantageous activity with multiple tumor types. However, the responses from Bevacizumab are often transient due to the tumor's manipulative abilities to circumvent the usual pathways to find salvage pathways instead. Nintedanib has demonstrated anti-tumor activity in non-squamous non-small cell lung cancer, colorectal cancer, ovarian cancer, and renal cell cancer. The combination of Bevacizumab and Nintedanib are being proposed to target the tumor's manipulation processes to generate alternate pathways for angiogenesis thus creating a potential benefit to delay tumor growth.

Key Dates

First listed
Jul 18, 2016
Start date
Jun 9, 2016
Status verified
Jul 2018
Primary completion
Apr 14, 2018
Completion
Jun 14, 2018

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nintedanib 150 mg + Bevacizumab 15 mg/kg
    The first three patients on study will be treated with 150 mg orally of Nintedanib two times daily plus 15 mg/kg of Bevacizumab administered intravenously on day one of each three week cycle. If one dose limiting toxicity occurs in the first cohort, then three more patients will be treated at that same starting dose and assessed for toxicity after cycle two. If two or more patients have dose limiting toxicity, then dose escalation will end and the maximum tolerated dose will be reached.
  • Experimental: Nintedanib 200 mg + Bevacizumab 15 mg/kg
    If no patients experience dose limiting toxicity, then three additional patients will be treated with 200 mg orally of Nintedanib two times daily plus 15 mg/kg of Bevacizumab administered intravenously on day one of each three week cycle.

Primary Outcome Measure

Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Initial dose of study drug until four weeks after the last dose or until death, whichever occurs first ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Comprehensive Cancer CenterBirminghamAlabama35294-

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By research site
University of Alabama at Birmingham Comprehensive Cancer Center· Birmingham, AL

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