An Efficacy and Safety Study of JNJ56021927 in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Janssen Cilag International

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

23 Apr 2015 → ongoing

Decision date (initial)

2024-02-05

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Janssen-Cilag International NV, Belgium

External identifiers

EU CT number

2023-508606-26-00

EudraCT number

2014-001718-25

ClinicalTrials.gov

NCT02257736

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenetic, Safety, Pharmacokinetic

The primary objective 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 subjects with chemotherapy-naïve mCRPC.

Secondary objectives 2

1. To characterize the safety profile of apalutamide in combination with AAP
2. To characterize the pharmacokinetics (PK) of apalutamide and abiraterone

Conditions and MedDRA coding

Metastatic castration-resistant prostate cancer (mCRPC)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Subject must be a man age ≥18 years of age, inclusive
2. Adenocarcinoma of the prostate
3. 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
4. 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)
5. Patients 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
6. Prostate cancer progression documented by prostate-specific antigen (PSA) according to the Prostate Cancer Clinical Trials Working Group (PCWG2); radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST) modified based on PCWG2, or radiographic progression of bone according to PCWG2.

Exclusion criteria 6

1. Small cell or neuroendocrine carcinoma of the prostate
2. Known brain metastases
3. Prior chemotherapy for prostate cancer, except if administered in the adjuvant/neoadjuvant setting
4. Previously treated with ketoconazole for prostate cancer for greater than 7 days
5. 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 nonherbal products that may decrease PSA levels (example [eg], saw palmetto, pomegranate) or c) Any investigational agent
6. At screening need for parenteral or oral opioid analgesics (eg, codeine, dextropropoxyphene)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is radiographic progression-free survival (rPFS).

Secondary endpoints 4

1. Overall survival (OS) is defined as the time from date of randomization to date of death from any cause.
2. Time to chronic opioid use (oral opioid use for ≥3 weeks; parenteral opioid use for ≥7 days) is defined as the time from date of randomization to the first date of opioid use
3. Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy
4. Time to pain progression defined as the time from date of randomization to the first date a subject experience an increase by 2 points from baseline in the BPI-SF worst pain intensity item 3 observed at 2 consecutive evaluations ≥4 weeks apart or initiation of chronic opioids, whichever occurs first

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Janssen Cilag International

Sponsor organisation

Janssen Cilag International

Address

Turnhoutseweg 30

City

Beerse

Postcode

2340

Country

Belgium

Scientific contact point

Organisation

Janssen Cilag International

Contact name

CTIS point of contact

Public contact point

Organisation

Janssen Cilag International

Contact name

CTIS point of contact

Third parties 2

Locations

3 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications