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Sponsored by: |
Nerviano Medical Sciences |
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Information provided by: | Nerviano Medical Sciences |
ClinicalTrials.gov Identifier: | NCT00766324 |
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.
Condition | Intervention | Phase |
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Metastatic Hormone Refractory Prostate Cancer |
Drug: PHA-739358 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of PHA-739358 in Patients With Metastatic Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 118 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: PHA-739358
6-hr IV infusion weekly for 3 consecutive weeks in a 4-week cycle
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B: Experimental |
Drug: PHA-739358
24-hr IV infusion every 2 weeks in a 4-week cycle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maria Gabriella Jannuzzo, PhD | +390331581475 | mariagabriella.jannuzzo@nervianoms.com |
Italy, Milano | |
Nerviano Medical Sciences. Clinical Research Dept. | Recruiting |
Nerviano, Milano, Italy, 20014 |
Responsible Party: | Nerviano Medical Sciences ( Clinical Research , Head ) |
Study ID Numbers: | AURA-6202-007 |
Study First Received: | October 2, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00766324 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Italy: Ethics Committee; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Netherlands: Medical Ethics Review Committee (METC) |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |