Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy (SUN 1120)

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Prostatic Neoplasms

Treatments: Drug: sunitinib; Drug: Placebo; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676650

A6181120

Details and patient eligibility

About

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Enrollment: 873 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate.
• Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
• Progressive disease based on PSA progression, RECIST, or positive bone scan.
• ECOG 0 or 1.

Exclusion criteria

• Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
• Chemotherapy within 3 weeks.
• Impending complications from bone metastases.
• Ongoing urinary obstruction.
• Cardiac dysfunction, QTc >470 msec.
• CNS involvement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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873 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Treatment Arm A - sunitinib + prednisone

Treatment:

Drug: Prednisone

Drug: Prednisone

Drug: sunitinib

B

Placebo Comparator group

Description:

Treatment Arm B - placebo + prednisone

Treatment:

Drug: Placebo

Drug: Prednisone

Drug: Prednisone