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

NCT01564914 | Completed Phase 2 Results

• 1 other identifier: 105GM201/Case 1312
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

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)

Conditions

Glioblastoma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival (OS)

  Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial

  6 Months

Secondary Outcomes (3)

• Median Duration That Patients Remained Progression Free on Study

  Patients are scanned every 8 weeks for approximately 6 months

• Number of Participants With Adverse Events

  Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months

• Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)).

  Patients are scanned every 8 weeks

Study Arms (1)

TRC105, Bevacizumab

EXPERIMENTAL

Single arm study

Drug: TRC105; Drug: Bevacizumab

Interventions

TRC105 DRUG

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

Also known as: carotuximab

TRC105, Bevacizumab

Bevacizumab DRUG

IV

Also known as: Avastin

TRC105, Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead
• The Cleveland Clinic: collaborator
• Case Comprehensive Cancer Center: collaborator

Study Sites (4)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

carotuximab; Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Monitor
• Organization: TRACON Pharmaceuticals

ctheuer@traconpharma.com

8585500780

Study Officials

• Charles Theuer, MD PhD

  Tracon Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 28, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-05

Locations

US (4)