Trial Title:
CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations
NCT ID:
NCT05689021
Condition:
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Prednisone
Cortisone
Abiraterone Acetate
Niraparib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone Acetate/Niraparib
Description:
Given PO
Arm group label:
Treatment (CJNJ-67652000 and prednisone)
Other name:
Abiraterone Acetate and Niraparib Tosylate Monohydrate
Other name:
Abiraterone Acetate/Niraparib Tosylate Monohydrate
Other name:
Akeega
Other name:
CJNJ-67652000
Other name:
Niraparib and Abiraterone Acetate
Other name:
Niraparib Tosylate Monohydrate and Abiraterone Acetate
Other name:
Niraparib Tosylate Monohydrate/Abiraterone Acetate
Other name:
Niraparib/Abiraterone Acetate
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood specimen collection
Arm group label:
Treatment (CJNJ-67652000 and prednisone)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Bone Scan
Description:
Undergo technetium-99m bone scan
Arm group label:
Treatment (CJNJ-67652000 and prednisone)
Other name:
Bone Scintigraphy
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (CJNJ-67652000 and prednisone)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (CJNJ-67652000 and prednisone)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Given PO
Arm group label:
Treatment (CJNJ-67652000 and prednisone)
Other name:
.delta.1-Cortisone
Other name:
1, 2-Dehydrocortisone
Other name:
Adasone
Other name:
Cortancyl
Other name:
Dacortin
Other name:
DeCortin
Other name:
Decortisyl
Other name:
Decorton
Other name:
Delta 1-Cortisone
Other name:
Delta-Dome
Other name:
Deltacortene
Other name:
Deltacortisone
Other name:
Deltadehydrocortisone
Other name:
Deltasone
Other name:
Deltison
Other name:
Deltra
Other name:
Econosone
Other name:
Lisacort
Other name:
Meprosona-F
Other name:
Metacortandracin
Other name:
Meticorten
Other name:
Ofisolona
Other name:
Orasone
Other name:
Panafcort
Other name:
Panasol-S
Other name:
Paracort
Other name:
Perrigo Prednisone
Other name:
PRED
Other name:
Predicor
Other name:
Predicorten
Other name:
Prednicen-M
Other name:
Prednicort
Other name:
Prednidib
Other name:
Prednilonga
Other name:
Predniment
Other name:
Prednisone Intensol
Other name:
Prednisonum
Other name:
Prednitone
Other name:
Promifen
Other name:
Rayos
Other name:
Servisone
Other name:
SK-Prednisone
Summary:
This phase II trial tests how well abiraterone acetate/niraparib (CJNJ-67652000
[niraparib/abiraterone acetate fixed-dose combination]) and prednisone works in treating
patients with castration-resistant prostate cancer that has spread from where it first
started (primary site) to other places in the body (metastatic) and who have a mutation
in the SPOP gene. CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination) is
a drug which stops certain cancer cells from being able to repair themselves from damage,
leading to the death of the cancer cell. Prednisone is in a class of medications called
corticosteroids. It is used to reduce inflammation and lower the body's immune response
to help lessen the side effects of chemotherapy drugs. Giving CJNJ-67652000 and
prednisone may kill more tumor cells in patients with metastatic prostate cancer than
giving these drugs alone.
Detailed description:
PRIMARY OBJECTIVE:
I. To determine the efficacy of abiraterone acetate/niraparib (CJNJ-67652000
[niraparib/abiraterone acetate fixed-dose combination]) and prednisone as assessed by
prostate-specific antigen decline >= 50% (PSA50) response rate in patients with
metastatic castrate-resistant prostate cancer (mCRPC) who have failed prior treatment
with androgen receptor (AR)-targeted therapy and have a qualifying, deleterious SPOP
mutation.
SECONDARY OBJECTIVES:
I. To assess the radiologic progression free survival (rPFS) of CJNJ-67652000
(niraparib/abiraterone acetate fixed-dose combination) and prednisone treatment in
patients with mCRPC who have failed prior treatment with AR-targeted therapy and have a
qualifying, deleterious SPOP mutation.
II. To assess best radiographic response using Prostate Cancer Working Group 3 (PCWG3)
criteria.
III. To assess time to prostate specific antigen (PSA) progression. IV. To assess safety
and tolerability using National Cancer Institute (NCI) Common Toxicity Criteria Version
5.0.
CORRELATIVE RESEARCH OBJECTIVES:
I. To explore the landscape of genomic alterations occurring after use of CJNJ-67652000
(niraparib/abiraterone acetate fixed-dose combination) and prednisone.
II. To use blood, tissue, or organoid lines for identifying predictive biomarkers of
response, investigating drug resistance mechanisms, and for future drug efficacy studies.
III. To explore the relationship of other genomic alterations in the tumor tissue with
overall response rate (ORR) and disease progression.
OUTLINE:
Patients receive CJNJ-67652000 orally (PO) and prednisone PO on study. Patients also
undergo blood specimen collection, computed tomography (CT) or magnetic resonance imaging
(MRI), and bone scan throughout the trial.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male >= 18 years of age
- Histological confirmation of adenocarcinoma of the prostate
- Qualifying deleterious SPOP mutation detected on any archival genomic assay (tissue
and/or liquid biopsy) is acceptable for study inclusion. Qualifying mutation(s) of
SPOP include any genomic change predicted to be deleterious or suspected
deleterious. SPOP status must be established prior to involvement on the trial
- Evidence of metastatic castration-resistant prostate cancer, defined as at least one
(1) documented metastatic lesion on either bone scan or CT scan. Bone only disease
is acceptable for enrollment. Non-bone metastatic lesions must be measurable by
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Subjects whose
disease spread is limited to regional pelvic lymph nodes or local recurrence (e.g.
bladder, rectum) are not eligible
- Radiographic or PSA progression while on androgen deprivation therapy (or after
bilateral orchiectomy) AND at least one prior AR-targeted therapy (abiraterone
acetate, enzalutamide, apalutamide, darolutamide or investigational AR-targeted
agents). PSA progression is a PSA increase that is >= 25% and >= 2 ng/mL above the
nadir, and which is confirmed by a second value (minimum 1 week interval between
tests). For radiographic progression of soft tissue lesions, modified RECIST 1.1
criteria will be used to qualify entry. For radiographic progression of bony
disease, two new lesions must be seen as per PCWG3 criteria. No confirmatory scan of
bone progression is required prior to study entry
- A maximum of two lines of prior taxane (docetaxel and/or cabazitaxel) chemotherapy
will be allowed, but are not required
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- Surgically or medically castrated, with serum testosterone levels of =< 50 ng/dL
(1.73 nM). For patients currently being treated with luteinizing hormone-releasing
hormone (LHRH) analogs (ie, patients who have not undergone an orchiectomy), therapy
must be continued throughout the study
- Absolute neutrophil count (ANC) >= 1500/mm^3 (within 14 days prior to registration)
- Platelet count >= 100,000/mm^3 (within 14 days prior to registration)
- Hemoglobin >= 10 g/dL independent of transfusion within 14 days
- Total bilirubin =< 1.5 x upper limit of normal (ULN) (In subjects with Gilbert's
syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin,
and if direct bilirubin is =< 1.5 x ULN, subject may be eligible as determined by
the medical monitor) (within 14 days prior to registration)
- Alanine aminotransferase (ALT) =< 3 x ULN (within 14 days prior to registration)
- Aspartate transaminase (AST) =< 3 x ULN (within 14 days prior to registration)
- Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula
(within 14 days prior to registration)
- Male patients who are committed to undertaking the following measures for the
duration of the study and after the last dose of CJNJ-67652000
(niraparib/abiraterone acetate fixed-dose combination) for the time period
specified:
- Use a condom during sex while being treated and for 120 days after the last
dose of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination)
- Do not make semen donations during treatment and for 120 days after the last
dose of CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose combination)
- Those with female partners of childbearing potential may be enrolled if they
are:
- Documented to be surgically sterile (ie, vasectomy);
- Committed to practicing true abstinence during treatment and for 120 days
after the last CJNJ-67652000 (niraparib/abiraterone acetate fixed-dose
combination) dose; or
- Committed to using an effective method of contraception with their partner
during treatment and for 120 days following the last dose of CJNJ-67652000
(niraparib/abiraterone acetate fixed-dose combination)
- Provide written informed consent
Exclusion Criteria:
- Prior treatment with PARP inhibitor or platinum chemotherapy
- Historical or current diagnosis of myelodysplastic syndrome or myeloid malignancy
- Any of the following prior therapies:
- Surgery =< 3 weeks prior to registration
- Chemotherapy =< 2 weeks prior to registration
- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry into
this study or interfere significantly with the proper assessment of safety and
toxicity of the prescribed regimens
- Clinician assessed prognosis of less than 16 weeks
- Human immunodeficiency virus (HIV) positive subjects with 1 or more of the
following:
- Not receiving highly active antiretroviral therapy
- Receiving antiretroviral therapy that may interfere with the study drug
(consult the sponsor for review of medication prior to enrollment)
- A change in antiretroviral therapy within 6 months of the start of screening
(except if, after consultation with the sponsor-investigator on exclusion
criterion, a change is made to avoid a potential drug-drug interaction with the
study drug)
- CD4 count < 350 at screening
- An acquired immunodeficiency syndrome-defining opportunistic infection within 6
months of the start of screening
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure (left ventricular ejection fraction [LVEF]
< 50% or New York Heart Association [NYHA] class III or IV heart failure)
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction within the last 6 months
- Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic
blood pressure [BP] >= 95 mmHg). Subjects with a history of hypertension are
allowed provided blood pressure is controlled by anti-hypertensive treatment
- Or psychiatric illness/social situations that would limit compliance with study
requirements
- Receiving any other investigational agent which would be considered as a treatment
for the primary neoplasm
- Other active malignancy =< 3 years prior to registration
- EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or
malignancy not expected to require therapy (systemic or radiation) in the next
1 year
- History of myocardial infarction =< 6 months
- Symptomatic brain metastases
- Current evidence of any of the following:
- Any medical condition that would make prednisone use contraindicated
- Any chronic medical condition requiring a higher dose of corticosteroid than 10
mg prednisone (or equivalent once daily
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Irbaz B. Riaz, MBBS, MS
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Winston Tan, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Daniel S. Childs, M.D.
Email:
Principal Investigator
Start date:
March 5, 2024
Completion date:
September 1, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05689021
https://www.mayo.edu/research/clinical-trials
