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OpenTrials
Completed

NCT Number: NCT00766324

PHA-739358 for Treatment of Hormone Refractory Prostate Cancer

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.

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Key information

Conditions

Metastatic Hormone Refractory Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Nerviano Medical Sciences. Clinical Research Dept.

Nerviano, Milano, 20014, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHA-739358

Drug

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

Primary outcomes

  1. PSA response rate defined according to the recommendations from the Prostate-Specific Antigen Working Group

    Time frame: within the first three months of treatment

Secondary outcomes

  1. Objective Response Rate, Progression Free Survival, additional PSA based endpoints, clinical benefit

    Time frame: all cycles

  2. Overall safety profile

    Time frame: all cycles

Sponsors and collaborators

Lead sponsor

Nerviano Medical Sciences

Industry

Registry information

Official study title

A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 3, 2008
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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