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Phase I Cabazitaxel, Mitoxantrone, and Prednisone Metastatic Castration-Resistant Prostate Cancer

NCT01594918 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-07-21

No results posted yet for this study

Summary

The purpose of this study is to test the safety of cabazitaxel, mitoxantrone, and prednisone (CAMP) in combination at different dose levels and to determine the highest dose that does not cause bad side effects. The investigators want to find out what effects, good and/or bad, CAMP has on patients and their metastatic castration-resistant prostate cancer.

Conditions

Interventions

DRUG

Cabazitaxel

25 mg/m2 or 20 mg/m2, IV, once every 21 days

DRUG

Mitoxantrone

4 mg/m2, 6 mg/m2, 8 mg/m2, 10 mg/m2, or 12 mg/m2, IV, once every 21 days

DRUG

Prednisone

5 mg PO BID

DRUG

Pegfilgrastim

6 mg, SC, once every 21 days

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Rahul Aggarwal

    lead OTHER

Principal Investigators

  • Rahul Aggarwal, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-08-31
Completion
2017-06-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01594918 on ClinicalTrials.gov