Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

Pfizer

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: MDV3100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565928

C3431002 (Other Identifier)

MDV3100-06

Details and patient eligibility

About

The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.

Enrollment: 23 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide informed consent;
• Men, 18 years of age or older;
• Histologically or cytologically confirmed adenocarcinoma of the prostate;
• Ongoing androgen deprivation therapy

Exclusion criteria

• Severe concurrent disease;
• Known or suspected brain metastasis;
• History of another malignancy within the previous 5 years;
• Prior treatment with docetaxel-based chemotherapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

MDV3100

Experimental group

Treatment:

Drug: MDV3100