NCT00777959

Brief Summary

This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2 prostate-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2.6 years

First QC Date

October 21, 2008

Last Update Submit

August 18, 2015

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • 30% Prostate specific antigen (PSA) decline within 12 weeks

    12 weeks

  • Number of dose limiting toxicities (DLTs)

    Day 1 to Day 35

Secondary Outcomes (4)

  • Prostate specific antigen (PSA) response rate

    12 weeks

  • Number of patients with progression free survival (PFS)

    12 weeks

  • Time to prostate specific antigen (PSA) progression

    12 weeks

  • Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus

    30 Minutes to 24 hour postdose

Study Arms (3)

Open Label

EXPERIMENTAL

ridaforolimus (MK8669)+ bicalutamide

Drug: open-label ridaforolimus (MK8669)

Ridaforolimus

EXPERIMENTAL

ridaforolimus (MK8669)+ bicalutamide

Drug: ridaforolimus (MK8669)

Placebo

PLACEBO COMPARATOR

Placebo + bicalutamide

Drug: Comparator: Placebo

Interventions

ridaforolimus (MK8669)DRUG

Three 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.

Also known as: AP23573
Ridaforolimus
Comparator: PlaceboDRUG

Three tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.

Placebo
open-label ridaforolimus (MK8669)DRUG

Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression.

Also known as: AP23573
Open Label

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed adenocarcinomas of the prostate.
  • Evidence of metastatic disease
  • Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
  • PSA level is greater or equal to 7 ng/ml.
  • ECOG performance status less than or equal to 1

You may not qualify if:

  • Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
  • Prior chemotherapy for prostate cancer
  • Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
  • Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
  • Patient has pain related to prostate cancer that warrants the initiation of chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.

    PMID: 23921574RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

August 19, 2015

Record last verified: 2015-08