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Pazopanib, Docetaxel, Prednisone Prostate

NCT01385228 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-06-06

No results posted yet for this study

Summary

The primary purpose is to define the safety and tolerability of docetaxel/prednisone in combination with pazopanib (DPP) in men with metastatic Castration Resistant Prostate Cancer (mCRPC).

Conditions

Interventions

DRUG

Pazopanib

Dose Level "Xa" - daily administration of pazopanib on days 1 through 21 starting at 400mg with a maximum dose of 1000mg.

DRUG

Docetaxel

Docetaxel given IV on Day 1 starting dose 60mg/m2 increase to 75mg/m2

DRUG

Pazopanib

Dose Level "Xb" - daily administration of pazopanib on days 3 through 19 starting at 400mg with a maximum dose of 1000mg.

DRUG

Prednisone

5mg Prednisone given twice daily days 1-21.

DRUG

Pegfilgrastim

Sponsors & Collaborators

Principal Investigators

  • Daniel J George, MD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2015-07-31
Completion
2016-02-29

Countries

  • United States

Study Locations

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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 NCT01385228 on ClinicalTrials.gov