A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab
This trial is active, not recruiting.
|Conditions||glioblastoma, glioblastoma multiforme|
|Treatment||chimeric monoclonal antibody (trc105) to cd105|
|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|
|Cincinnati, OH||University of Cincinnati||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Cleveland, OH||University Hospitals of Cleveland||no longer recruiting|
|Columbus, OH||Ohio State University||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Determine median overall survival (OS) in patients with recurrent or progressive GBM who have progressed on bevacizumab.
time frame: 6 Months
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
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
|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.|
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