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A Study of Pertuzumab in Participants With Prostate Cancer

NCT02480010 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2015-09-18

Study results available
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Summary

This study will evaluate the efficacy and safety of intravenous (IV) pertuzumab in participants with hormone-refractory prostate cancer who have had no previous chemotherapy. Participants will be enrolled in two stages, the first (Cohort A) at a lower 420-mg dose and the second (Cohort B) at a higher 1050-mg dose based upon observations in Cohort A. Up to 50 participants may enter either cohort, for a total enrollment between 46 and 73 participants across 9 study centers.

Conditions

Interventions

DRUG

Pertuzumab

Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2005-09-30
Completion
2005-09-30

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

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 NCT02480010 on ClinicalTrials.gov