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

Novartis

Status and phase: Completed; Phase 2

Conditions: Metastatic Hormone Refractory Prostate Cancer

Treatments: Drug: prednisone; Drug: docetaxel; Drug: Patupilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411528

CEPO906A2229

2006-001822-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be ≥ 18 years of age
• Confirmed and documented diagnosis of prostate cancer
• Confirmed and documented evidence of progression of disease (hormone refractory)
• Low testosterone levels
• Chemotherapy-naïve

Exclusion criteria

• Recent radiation therapy (within 4 weeks)
• Known brain metastasis
• Peripheral neuropathy
• Active diarrhea
• Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
• Allergic reactions to patupilone or docetaxel or prednisone or similar compounds

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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185 participants in 4 patient groups

1: 8 mg/m2 study drug + prednisone

Experimental group

Description:

Patupilone 8 mg/m2 + prednisone 5 mg bid daily

Treatment:

Drug: Patupilone

Drug: prednisone

2: study drug + prednisone days 1 -8

Experimental group

Description:

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

Treatment:

Drug: Patupilone

Drug: prednisone

3: Study drug + prednisone days 1 - 4

Experimental group

Description:

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

Treatment:

Drug: Patupilone

Drug: prednisone

4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily

Active Comparator group

Description:

Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily

Treatment:

Drug: docetaxel

Drug: prednisone