PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

NCT ID: NCT00766324

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the antitumor activity of PHA-739358 administered as IV infusion according to two different dose schedules in metastatic HRPC patients progressing on standard, docetaxel-based 1st-line chemotherapy for HRPC based on PSA response, and to select the best dose schedule for further investigation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Hormone Refractory Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

PHA-739358

Intervention Type DRUG

6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle

B

Group Type EXPERIMENTAL

PHA-739358

Intervention Type DRUG

24-hr IV infusion every 2 weeks in a 4-week cycle

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PHA-739358

6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle

Intervention Type DRUG

PHA-739358

24-hr IV infusion every 2 weeks in a 4-week cycle

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Metastatic hormone refractory prostate cancer progressing after docetaxel based therapy
* Adequate bone marrow, liver and kidney function

Exclusion Criteria

* More than one prior chemotherapy line
* Uncontrolled hypertension
* Brain or leptomeningeal disease
* Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the previous 6 months
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nerviano Medical Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nerviano Medical Sciences. Clinical Research Dept.

Nerviano, Milano, Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AURA-6202-007

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

BN83495 in Prostate Cancer
NCT00790374 COMPLETED PHASE1