Study of TRC105 Combined With Standard-Dose Bevacizumab for Advanced Solid Tumors for Which Bevacizumab is Indicated

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Tracon Pharmaceuticals Inc.
Study ID
NCT01332721
Phase
PHASE1
Status
Completed

Conditions

  • Adult Solid Tumor

Eligibility Criteria

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

Interventions

  • TRC105 and Bevacizumab — DRUG
    Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Study Details

The purpose of the study is to evaluate safety and tolerability and determine a recommended Phase 2 dose for TRC105 when added to standard dose bevacizumab in patients with advanced solid tumors for which bevacizumab is indicated.

Key Dates

First listed
Apr 11, 2011
Start date
Apr 30, 2011
Status verified
Nov 2018
Primary completion
Sep 30, 2012
Completion
Dec 31, 2013

Study Design

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

Arms

  • Experimental: TRC105 and Bevacizumab
    Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.

Primary Outcome Measure

Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab [ Time Frame: 1.5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
Pinnacle Oncology HematologyScottsdaleArizona85258-
UCLA Hematology and OncologySanta MonicaCalifornia90404-
Indiana University Simon Cancer CenterIndianapolisIndiana46202-

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