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A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab

Descriptive Information
Brief Title † A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab
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
Brief Summary 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)
Detailed 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.
Study Phase Phase 2
Study Type † Interventional
Study Design † Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † Determine median overall survival (OS) in patients with recurrent or progressive GBM who have progressed on bevacizumab.
Secondary Outcome Measure † Determine the rate of progression free survival at 6 months (PFS-6).
Condition † Glioblastoma Glioblastoma Multiforme
Intervention † BiologicalChimeric monoclonal antibody (TRC105) to CD105
Study Arms / Comparison Groups TRC105
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 22
Start Date † May 2012
Completion Date June 2015
Primary Completion Date June 2015
Eligibility Criteria † 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
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT01564914
Organization ID 105GM201/Case 1312
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Tracon Pharmaceuticals Inc.
Collaborators †† The Cleveland Clinic
Investigators † : ,
Information Provided By
Verification Date May 2014
First Received Date † March 26, 2012
Last Updated Date July 16, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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