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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00748358 |
as second-line treatment in metastatic prostate cancer, the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6 cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be treated until disease progression, pain progression, unacceptable toxicity or death due to any cause.
Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.
Follow-up for up to 1 year from the last dose of sunitinib.
Condition | Intervention | Phase |
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Prostatic Neoplasms Neoplasms, Hormone-Dependent Tumor Markers, Biological Survival Rate Disease-Free Survival |
Drug: sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Phase II Study of Oral Treatment With Sunitinib (SUTENT) in Patients Suffering From Hormone Refractory Prostate Cancer After Progression With Docetaxel Based Regimen |
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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drug: Experimental
drug
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Drug: sunitinib
37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.
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Antitumor efficacy of sunitinib will be assessed as follows:
The biological effects of sunitinib in patients with metastatic prostate carcinoma will be evaluated by measurements of the different biological markers that could be modulated by this antiangiogenic therapeutic, and could then predict and monitor disease progression and response to treatment:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephane OUDARD, Professor | +33 (0)1 56 09 34 76 | stephane.oudard@egp.aphp.fr |
France | |
Service Oncologie Médicale, Hopital Europeen Georges Pompidou | Recruiting |
paris, France, 75015 |
Principal Investigator: | stephane OUDARD, professor | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Zakia IDIR ) |
Study ID Numbers: | P070404 |
Study First Received: | September 5, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00748358 |
Health Authority: | France: Ministry of Health |
metastatic prostate carcinoma sunitinib [Substance Name] Clinical Trial, Phase II [Publication Type] |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Sunitinib Neoplasms, Hormone-Dependent |
Disease Progression Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms Carcinoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |