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Completed

NCT Number: NCT01564914

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Cincinnati, Cincinnati, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRC105

Drug

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

Other names: carotuximab

Bevacizumab

Drug

IV

Other names: Avastin

Primary outcomes

  1. Median Overall Survival (OS)

    Time frame: 6 Months

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

Secondary outcomes

  1. Median Duration That Patients Remained Progression Free on Study

    Time frame: Patients are scanned every 8 weeks for approximately 6 months

    The median number of months that patients remained progression free was calculated using modified RANO criteria to determine progression. Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored.

  2. Number of Participants With Adverse Events

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

    Adverse event frequency per patient according to CTCAE version 4.0.

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

    Time frame: Patients are scanned every 8 weeks

    Number of patients who respond to study treatment according to modified RANO criteria was calculated (Objective Response Rate (ORR)). Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored.

Sponsors and collaborators

Lead sponsor

Tracon Pharmaceuticals Inc.

Industry

Collaborators

  • Case Comprehensive Cancer Center
  • The Cleveland Clinic

Registry information

Official study title

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

Acronym: 105GM201

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2012
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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