A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer, Metastatic Castrate Resistant Prostate Cancer

In brief

Background: * Currently, there is no curative therapy for metastatic castrate-resistant prostate cancer (CRPC), a leading cause of death in men. However, researchers are exploring new treatments that involve drugs that prevent angiogenesis (the process by which new blood vessels are formed) and can slow or prevent tumor growth. * TRC105 is an experimental drug that blocks angiogenesis, and has been studied for possible use in treating different kinds of cancer. However, it has not been validated to treat prostate cancer in general or CRPC in particular. Objectives: * To determine the effects of TRC105 as a treatment for CRPC * To determine the safety and effectiveness of TRC105 in treating CRPC Eligibility: \- Men at least 18 years of age who have been diagnosed with castrate-resistant prostate cancer for which existing treatments have not been effective. Design: * Eligible individuals will have a series of blood and other tests to determine their suitability for participating in the study. * Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle. Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days 1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8, 15, and 22 of each 28 day cycle (cohort 4). * Participants will receive different doses of TRC105 depending on when they enter the study, up to a maximum tolerated dose or optimum treatment dose. * Frequent blood and urine tests will be performed during treatment, as well as other tests of cancer progression as directed by the study doctors. Participants will receive medicines to help prevent possible adverse side effects of TRC105, such as allergic reaction to the drug. * Participants will continue treatment with TRC105 until they or the study team decides that the medication is not beneficial. No additional testing will be required unless participants discontinue the treatment because of side effects (which the study doctors will follow until the side effects are resolved).

Key facts

Study ID: NCT01090765
Run by: National Cancer Institute (NCI)
People needed: 21
Starts: 2010-02-23
Expected to finish: 2015-04-17
Last updated by the study team: 2018-05-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

Patients who have had chemotherapy, large field radiotherapy, or major surgery must wait 3 weeks prior to entering the study.
Patients may not be receiving any agents not approved by the Food and Drug Administration (FDA) within the past 4 weeks.
Patients with known brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Proteinuria, as demonstrated by a 24 hour protein of (Bullet) 2000 mg. Urine protein will be screened by urine protein-creatinine ratio (UPC). For UPC ratio > 1.0, a 24-hour urine protein will need to be obtained and the level should be < 2000 mg for patient enrollment.
Uncontrolled intercurrent illness including, but not limited to, hypertension (systolic blood pressure (BP) > 160, diastolic BP > 100), ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements.
Thrombolytic or treatment-dose anticoagulant use within 10 days prior to first dose with TRC105.
Hemorrhage within 30 days of dosing.
History of peptic ulcer disease or gastritis within 6 months of TRC105 administration, unless patient has received adequate treatment for peptic ulcer disease and has evidence of complete resolution documented by esophagogastroduodenoscopy (EGD).
Corrected QT interval (QTc) > 500 msec.
Known human immunodeficiency virus (HIV)-positive patients are excluded.
History of hypersensitivity reaction to human or mouse antibody products.
Patients with a history of familial bleeding disorders.
Patients with a history of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome).
Use of non-steroidal anti-inflammatory drugs (NSAIDs) beginning 14 days prior to the first TRC105 dose, with the exception of aspirin when clinically indicated.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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