Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer
- Registration Number
- NCT01565928
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
- 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
- Severe concurrent disease;
- Known or suspected brain metastasis;
- History of another malignancy within the previous 5 years;
- Prior treatment with docetaxel-based chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MDV3100 MDV3100 -
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2 Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days) 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.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Abnormalities in Vital Signs T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5 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".
Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG) T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5 Clinically significant changes from baseline in ECG findings was based up on investigator's discretion. T1 = Timeframe for "Combination Therapy: Docetaxel 75 mg/m\^2+ Enzalutamide 160 mg" and T2 = Time frame for "Post-Docetaxel Enzalutamide 160 mg".
Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 AUClast was observed using a linear mixed-effects model.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2 AUCinf was observed using a linear mixed-effects model.
Trial Locations
- Locations (3)
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States