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

NCT01090765 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-05-22

Study results available
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Summary

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).

Conditions

Interventions

DRUG

TRC105

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • William L Dahut, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-23
Primary Completion
2014-04-01
Completion
2015-04-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01090765 on ClinicalTrials.gov