Efficacy and Safety of Patupilone in Men (≥18 Years) With... | NCT00411528

ID	Type	Description	Link
2006-001822-23	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: 8 mg/m2 study drug + prednisone	Experimental	Patupilone 8 mg/m2 + prednisone 5 mg bid daily	Drug: Patupilone Drug: prednisone
2: study drug + prednisone days 1 -8	Experimental	Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 - 21 at 5 mg bid	Drug: Patupilone Drug: prednisone
3: Study drug + prednisone days 1 - 4	Experimental	Patupilone 10 mg/m2 + prednisone days 1 - 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 - 21 at 5 mg bid	Drug: Patupilone Drug: prednisone
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily	Active Comparator	Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily	Drug: prednisone Drug: docetaxel

Name	Type	Description	Arm Group Labels	Other Names
Patupilone	Drug		1: 8 mg/m2 study drug + prednisone 2: study drug + prednisone days 1 -8 3: Study drug + prednisone days 1 - 4

Outcomes Module

Measure	Description	Time Frame
Antitumor response based on PSA decrease		Every 3 weeks

Measure	Description	Time Frame
Measurable soft tissue response for both regimens		Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Diego Dept of Moores Cancer Center		La Jolla	California	92093-0658	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24722180	Derived	de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

Label	URL
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.	View source

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

Ancestor Terms