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Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate Cancer

NCT00574769 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-04-11

No results posted yet for this study

Summary

Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).

Conditions

Interventions

DRUG

RAD001, Docetaxel, Bevacizumab

RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m\^2 every 21 days

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • University of Southern California

    lead OTHER

Principal Investigators

  • Mitchell E Gross, MD, Ph.D · University of Southern California

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-17
Primary Completion
2016-02-17
Completion
2017-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00574769 on ClinicalTrials.gov