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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, Glioblastoma Multiforme

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Trial Information

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


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.


Inclusion Criteria:



1. Patients with histologically confirmed glioblastoma or other grade IV malignant
glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior
external-beam fractionated radiotherapy and temozolomide chemotherapy.

2. Patients with documented radiographic progression following bevacizumab therapy for
treatment of glioblastoma or other grade IV malignant glioma (the patient must be on
bevacizumab at the time of last progression).

3. Patients with up to 2 prior recurrences are allowed.

4. Karnofsky performance status ≥ 60%.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine median overall survival (OS) in patients with recurrent or progressive GBM who have progressed on bevacizumab.

Outcome Time Frame:

6 Months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

105GM201/Case 1312

NCT ID:

NCT01564914

Start Date:

May 2012

Completion Date:

June 2015

Related Keywords:

  • Glioblastoma
  • Glioblastoma Multiforme
  • Glioblastoma

Name

Location

University Hospitals of ClevelandCleveland, Ohio  44106
Cleveland ClinicCleveland, Ohio  44195
University of CincinnatiCincinnati, Ohio  45267-0502