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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-06-30

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Glioblastoma Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A total of 6 initial patients were treated with 10 mg/kg of TRC105 monotherapy. All patients progressed within 2 months of initiating treatment, reflecting the rapid progression. Due to the lack of activity in this disease setting with TRC105 alone, the study was amended to treat patients with 10 mg/kg TRC105 weekly in combination with 10 mg/kg bevacizumab every two weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TRC105, Bevacizumab

Single arm study

Group Type EXPERIMENTAL

TRC105

Intervention Type DRUG

10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle

Bevacizumab

Intervention Type DRUG

IV

Interventions

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TRC105

10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle

Intervention Type DRUG

Bevacizumab

IV

Intervention Type DRUG

Other Intervention Names

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carotuximab Avastin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No