Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

MDV3100

Pfizer Pfizer CT.gov Call Center

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

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

A PHASE 1B, OPEN-LABEL, SAFETY AND TOLERABILITY STUDY OF ORAL MDV3100 IN COMBINATION WITH DOCETAXEL IN MEN WITH ADVANCED PROSTATE CANCER

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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.

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.

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".

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".

AUClast was observed using a linear mixed-effects model.

AUCinf was observed using a linear mixed-effects model.

Astellas Pharma Inc

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Pfizer

An event may be categorized as serious in one participant and non-serious in another, or 1 participant may experience both event. All treatment emergent AEs and SAEs were collected and reported. The same event may appear as both AE and SAE. Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

Docetaxel 75 mg/m\^2 was administered as IV infusion for 1 hour on Day 1 in each treatment period (each treatment period was of 21 days). From Day 2 of treatment Period 1 participants received a single oral dose of Enzalutamide 160 mg once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone 5 mg once daily on the days of docetaxel administration then twice daily every day thereafter as long as docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide received the both.

Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg

Participants who had received the combination therapy of Docetaxel and Enzalutamide but discontinued the Docetaxel treatment and continued to receive a single oral dose of Enzalutamide 160 mg (4 capsule each of 40 mg) once daily up to the end of the study treatment (maximum of 70 months).

Post-Docetaxel Enzalutamide 160 mg

Docetaxel 75 milligrams per square meter (mg/m\^2) was administered as intravenous (IV) infusion for 1 hour on Day 1 of each treatment period (each treatment period was of 21 days). From Day 2 of treatment period 1, participants received a single oral dose of Enzalutamide (MDV3100) 160 milligrams (mg) (4 capsules of 40 mg each) once daily. Participants received a single oral dose of Dexamethasone 8 mg prior to each Docetaxel infusion and Prednisone (5 mg) once daily on the days of Docetaxel administration then twice daily every day thereafter as long as Docetaxel treatment continued. Participants who tolerated treatment with Docetaxel and Enzalutamide continued to receive the combined therapy. Participants who discontinued Docetaxel were allowed to continue the treatment with Enzalutamide 160 mg once daily up to the end of study treatment (maximum of Month 70).

Docetaxel 75 mg/m^2+ Enzalutamide 160 mg

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Intent-to-treat (ITT) population included all enrolled participants.

Pfizer ClinicalTrials.gov Call Center

Docetaxel Dose Reductions

Enzalutamide Dose Reductions

Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).

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

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

SBP: AR- > 180 mmHg, increase from BL > 40 mmHg

SBP: AR- < 90 mmHg, decrease from BL > 30 mmHg

SBP: Most extreme post- BL result >= 140 mmHg

SBP: Most extreme post- BL result >= 180 mmHg

SBP: MER >= 180 mmHg, >= 20 mmHg change from BL

SBP: MER >= 140 mmHg, >= 20 mmHg change from BL

DBP: Most extreme post-BL result >= 90 mmHg

DBP: Most extreme post-BL result >= 105 mmHg

DBP: MER >= 105 mmHg,>= 15 mmHg change from BL

DBP: MER >= 90 mmHg,>= 15 mmHg change from BL

Heart Rate: AR >120 bpm, increase from BL >30 bpm

Heart Rate: AR <50 bpm, decrease from BL >30 bpm

Number of Participants With Clinically Significant Abnormalities in Vital Signs

Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG)

Docetaxel Without Enzalutamide

Docetaxel With Enzalutamide

Pharmacokinetic (PK) population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m\^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.

Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment

PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m\^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment

Spots Global Cancer Trial Database for Safety and Tolerability Study of MDV3100 in Combination With Docetaxel in Men With Advanced Prostate Cancer

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Study Description

Keywords

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