Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

Phase 2

Completed

• Conditions: Metastatic Hormone Refractory Prostate Cancer
• Interventions: Drug: Patupilone; Drug: prednisone; Drug: docetaxel

• Registration Number: NCT00411528
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-14
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-26
• Status Verified: 2020-09
• Disposition First Posted: 2020-09-02
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 185

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1: 8 mg/m2 study drug + prednisone	Patupilone	Patupilone 8 mg/m2 + prednisone 5 mg bid daily
1: 8 mg/m2 study drug + prednisone	prednisone	Patupilone 8 mg/m2 + prednisone 5 mg bid daily
2: study drug + prednisone days 1 -8	prednisone	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
3: Study drug + prednisone days 1 - 4	Patupilone	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
2: study drug + prednisone days 1 -8	Patupilone	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
3: Study drug + prednisone days 1 - 4	prednisone	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
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily	prednisone	Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily	docetaxel	Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily

Primary Outcome Measures

Name	Time	Method
Antitumor response based on PSA decrease	Every 3 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (12)

University of Colorado Dept. of Univ. of Colorado; 🇺🇸 Aurora, Colorado, United States

University of California San Diego Dept of Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Norwalk Hospital; 🇺🇸 Norwalk, Connecticut, United States

Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

MD Anderson Cancer Center - Orlando CEPO906A2229; 🇺🇸 Orlando, Florida, United States

NorthWest Georgia Oncology Centers Marietta Center; 🇺🇸 Marietta, Georgia, United States

H. Lee Moffitt Cancer Center/University of South Florida Department of Genitourology; 🇺🇸 Tampa, Florida, United States

Palm Beach Cancer Institute; 🇺🇸 West Palm Beach, Florida, United States

University Chicago Hospital StudyCoordinator:CEPO906A2229; 🇺🇸 Chicago, Illinois, United States

Novartis Investigative Site; 🇪🇸 Madrid, Spain

Oregon Health & Science University StudyCoordinator:CEPO906A2229; 🇺🇸 Portland, Oregon, United States

Queens Cancer Center of Queens Hospital; 🇺🇸 Jamaica, New York, United States