Phase 2
Completed N=22
A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With Glioblastoma
Source: ClinicalTrials.gov NCT01564914 ↗Enrolled (actual)
22
Serious AEs
40.9%
Results posted
Jun 2019
Primary outcomePrimary: Median Overall Survival (OS) — 5.75 months
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Overall Survival (OS) |
5.75 | — |
| SECONDARY Median Duration That Patients Remained Progression Free on Study |
1.81; 1.38 | — |
| SECONDARY Number of Participants With Adverse Events |
6; 3; 2; 0 | — |
| SECONDARY Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)). |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with histologically confirmed glioblastoma, recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
- Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma.
- Patients with up to 3 prior recurrences are allowed.
- Karnofsky performance status ≥ 70%.
- Age ≥ 18 years old.
- 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
Data sourced from ClinicalTrials.gov (NCT01564914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.