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

Pfizer23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

MDV3100DRUG

4 x 40 mg capsules, orally, once per day

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2

Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.

Time frame: Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)

Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)

AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure.

Time frame: Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months)

Secondary Outcomes

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Criteria:1)systolic blood pressure (SBP):a) absolute result(AR)\>=180millimeters of mercury(mmHg) and increase from baseline(BL)greater than(\>)40mmHg,b)less than(\<)90mmHg and decrease from BL\>30mmHg,c)most extreme post-BL result\>=140mmHg,d)most extreme post-BL result\>=180mmHg,e)most extreme result(MER)\>=180mmHg and \>=20mmHg change from BL,f)MER\>=140mmHg and \>=20mmHg change from BL;2)diastolic blood pressure(DBP):a)AR\>105mmHg and increase from BL,b)AR\<50mmHg and decrease from BL\>20mmHg;c)most extreme post-BL result\>=90mmHg,d)MER\>=90mmHg and \>=15mmHg change from BL,e)most extreme post-BL result\>=105mmHg,f)MER\>=105mmHg and\>=15mmHg change from BL;3)heart rate:a)AR\>120 beats per minute(bpm) and increase from BL\>30bpm,b) AR\<50 bpm and decrease from BL\>20bpm.Only those categories in which at least 1 participant had clinically significant vital sign abnormality, were reported in this outcome measure.T1 = Timeframe for "Combination Therapy" and T2 = Time frame for "Post-Docetaxel Enzalutamide".

Data from ClinicalTrials.gov

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