Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer
NCT00137436
ABOUT THIS STUDY
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- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
- Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF
receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or
anti-angiogenic treatment of any kind including investigational therapy
- Prior chemotherapy
- Uncontrolled pain at baseline, impending complication from bone metastasis (fracture
and/or compression) and/or presence of urinary obstruction (urinary retention,
hydronephrosis)
- History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec
- Central Nervous System (CNS) involvement
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Descriptive Information | ||||
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Brief Title ICMJE | Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer | |||
Official Title ICMJE | A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC) | |||
Brief Summary | This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Prostatic Neoplasms | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Experimental: A
SU011248 in combination with docetaxel and prednisone Interventions:
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 93 | |||
Original Enrollment ICMJE | 72 | |||
Actual Study Completion Date ICMJE | March 2010 | |||
Actual Primary Completion Date | May 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00137436 | |||
Other Study ID Numbers ICMJE | A6181043 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | August 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |