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Trial record 3 of 3 for:    Janssen 3001 | prostate cancer

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT02257736
Recruitment Status : Active, not recruiting
First Posted : October 6, 2014
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Aragon Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 2, 2014
First Posted Date  ICMJE October 6, 2014
Last Update Posted Date September 21, 2020
Actual Study Start Date  ICMJE November 26, 2014
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
Radiographic Progression-free Survival (rPFS). [ Time Frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years ]
Radiographic progression of bone is determined if there are more than or equal (>=) to 2 new lesions if less than (<) 12 weeks from randomization and there are 2 additional new lesions when observed 6 weeks later or, >= 2 new lesions after more than 12 weeks from randomization and the same is confirmed 6 weeks later or, progression of soft tissue lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
Radiographic Progression-free Survival (rPFS). [ Time Frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years ]
Radiographic progression is determined if there are more than or equal (>=) to 2 lesions in less than (<) 12 weeks from randomization and there are 2 new lesions when observed 6 weeks later or, >= 2 lesions after 12 weeks and the same is confirmed 6 weeks later or, progression of soft tissue lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2014)
  • Overall Survival (OS) [ Time Frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to 5 years ]
    The OS is defined as the time from randomization to date of death from any cause.
  • Time to Chronic Opioid Use [ Time Frame: Baseline up to 5 years ]
    Time to chronic opioid use is defined as the time from date of randomization to the first date of opioid use.
  • Time to Initiation of Cytotoxic Chemotherapy [ Time Frame: Baseline up to 5 years ]
    Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.
  • Time to Pain Progression [ Time Frame: Baseline up to 5 years ]
    Time to pain progression is defined as time from randomization to progression in worst pain over the last 24 hours (item 3) in the Brief pain inventory-short form (BPI-SF). BPI-SF is a self-evaluated pain assessment form consisting of 15 items. The Worst Pain-item 3 of the BPI-SF scale is used to assess pain on 11-point Likert scale which has range: 0 (no pain) to 10 (pain as bad as you can imagine).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official Title  ICMJE A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
Brief Summary The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).
Detailed Description This is a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participant know the treatment) placebo-controlled and multicenter (when more than 1 hospital or medical school team work on a medical research study) study to determine if participants with chemotherapy-naive mCRPC will benefit from the addition of apalutamide to AAP compared with AAP alone. The study consists of 3 phases: Screening phase; Treatment phase, and Follow-up phase. At the final analysis, the study will be unblinded. After the Independent Data Monitoring Committee (IDMC) review and the sponsor's subsequent decision participants will be offered to receive treatment either in the Open-Label Extension Phase or the Long-Term Extension Phase of study. Participants' safety will be monitored throughout the study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE
  • Drug: Apalutamide
    Participants will receive 240 mg (4*60 mg tablets) of apalutamide once daily orally.
  • Drug: Abiraterone acetate
    Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.
    Other Name: ZYTIGA
  • Drug: Prednisone
    Participants will receive 5 mg tablet of prednisone twice daily orally.
  • Drug: Placebo
    Participants will receive matching placebo to apalutamide once daily orally.
Study Arms  ICMJE
  • Experimental: Group 1: AAP and apalutamide
    Participants will receive apalutamide 240 milligram (mg) (4*60 mg tablets) and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily, until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the Open-Label Extension (OLE) or Long-Term Extension (LTE) phase (AAP + open label apalutamide or AAP alone).
    Interventions:
    • Drug: Apalutamide
    • Drug: Abiraterone acetate
    • Drug: Prednisone
  • Placebo Comparator: Group 2: AAP and Placebo
    Participants will receive matching Placebo of apalutamide and abiraterone acetate (AA) 1000 mg (4*250 mg tablets) once daily on an empty stomach and 5 mg prednisone (P), AAP, twice daily until disease progression, unacceptable toxicity or end of treatment, whichever occurs first. After unblinding participants will be offered further treatment as defined in the OLE or LTE phase (AAP + open label apalutamide or AAP alone).
    Interventions:
    • Drug: Abiraterone acetate
    • Drug: Prednisone
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
983
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2014)
960
Estimated Study Completion Date  ICMJE August 24, 2021
Actual Primary Completion Date March 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adenocarcinoma of the prostate
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). If lymph node metastasis is the only evidence of metastasis, it must be greater than or equal to (>=) 2 centimeter (cm) in the longest diameter
  • Castration-resistant prostate cancer demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of PSA, at least 1 week apart with the last androgen deprivation therapy (PSA) >= 2 nanogram per milliliters (ng/mL)
  • Participants who received a first generation anti-androgen (eg, bicalutamide, flutamide, nilutamide) must have at least a 6-week washout prior to randomization and must show continuing disease (PSA) progression (an increase in PSA) after the washout period
  • Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2) or radiographic progression of soft tissue according to modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2
  • Participants who cross-over from Prednisone alone to open-label apalutamide plus AAP should still be in the double-blind phase of the study, should be receiving AAP alone and should have ECOG 0-1-2.

Exclusion Criteria:

  • Small cell or neuroendocrine carcinoma of the prostate
  • Known brain metastases
  • Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
  • Previously treated with ketoconazole for prostate cancer for greater than 7 days
  • Therapies that must be discontinued or substituted at least 4 weeks prior to randomization include the following: a) Medications known to lower the seizure threshold, b) Herbal and non-herbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
  • At Screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Russian Federation,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02257736
Other Study ID Numbers  ICMJE CR105505
56021927PCR3001 ( Other Identifier: Janssen Research & Development, LLC )
2014-001718-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aragon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Aragon Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Aragon Pharmaceuticals, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP