This trial is active, not recruiting.

Conditions glioblastoma, glioblastoma multiforme
Treatment chimeric monoclonal antibody (trc105) to cd105
Phase phase 2
Sponsor Tracon Pharmaceuticals Inc.
Collaborator The Cleveland Clinic
Start date May 2012
End date June 2015
Trial size 22 participants
Trial identifier NCT01564914, 105GM201/Case 1312


The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF therapy)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
chimeric monoclonal antibody (trc105) to cd105
10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle

Primary Outcomes

Determine median overall survival (OS) in patients with recurrent or progressive GBM who have progressed on bevacizumab.
time frame: 6 Months

Secondary Outcomes

Determine the rate of progression free survival at 6 months (PFS-6).
time frame: 6-12 Months
Determine the median time to progression.
time frame: 2 Years
Assess safety and tolerability of TRC105 when given with bevacizumab by CTCAE version 4.0.
time frame: 6-12 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy. 2. Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma. 3. Patients with up to 3 prior recurrences are allowed. 4. Karnofsky performance status ≥ 70%. 5. Age ≥ 18 years old. 6. Normal organ function Exclusion Criteria: - Patients who have had previous treatment with TRC105. - Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury - Patients with cirrhosis, or active viral or nonviral hepatitis. - Patients with active bleeding or pathologic conditions that carry a high risk of bleeding,(i.e. hereditary hemorrhagic telangiectasia). - Patients who are currently receiving anticoagulation treatment - Patients unwilling or unable to comply with the protocol

Additional Information

Official title A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab
Description Angiogenesis plays a central role in the progression of solid cancer. TRC105 is an antibody to CD105, an important non-VEGF angiogenic target on proliferating endothelial cells. TRC105 inhibits angiogenesis, tumor growth and metastases in preclinical models. TRC105 has been well tolerated in patients with glioblastoma (GBM) as a single agent. The combination of TRC105 in combination with bevacizumab has demonstrated activity in bevacizumab refractory cancer patients. We hypothesize that TRC105 when administered with bevacizumab will have activity in GBM patients who progress on bevacizumab. By targeting a non-VEGF pathway, TRC105 has the potential to complement VEGF inhibition by bevacizumab, which could represent a major advance in GBM therapy.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Tracon Pharmaceuticals Inc..