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

NCT01565928 | Completed Phase 1 Results

• 2 other identifiers: MDV3100-06C3431002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; docetaxel; MDV3100; enzalutamide; Xtandi

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

Study Arms (1)

MDV3100

EXPERIMENTAL

Drug: MDV3100

Interventions

MDV3100 DRUG

4 x 40 mg capsules, orally, once per day

MDV3100

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead
• Astellas Pharma Inc: collaborator
• Medivation LLC, a wholly owned subsidiary of Pfizer Inc.: collaborator

Study Sites (3)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: March 29, 2012
• Study Start: January 24, 2012
• Primary Completion: July 1, 2013
• Study Completion: February 26, 2018
• Last Updated: April 22, 2019
• Results First Posted: April 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)