A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With Glioblastoma

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tracon Pharmaceuticals Inc.
• Collaborators: Case Comprehensive Cancer Center; The Cleveland Clinic
• Treatments: Bevacizumab

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