Metastatic Castration-resistant Prostate Cancer, MCRPCPhase 2NCT06890832
A Study to Investigate Efficacy and Safety of Different Dose Regimen of Oral Cabazitaxel Tablet in Adult Participants with Prostate Cancer
A Phase 2 study testing 50 mg cabazitaxel, 100 mg cabazitaxel and 200 mg cabazitaxel in people with Metastatic Castration-resistant Prostate Cancer, MCRPC, run by Jina Pharmaceuticals Inc..
Trial summary
A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, MCRPC
- What is being tested?
- 50 mg cabazitaxel, 100 mg cabazitaxel and 200 mg cabazitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study.
- Male participant ≥18 years of age at the time of signing the informed consent.
- Participant must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- Evidence of metastatic disease.
- Participant must be previously treated with a docetaxel-containing regimen (at least 3 cycles) for the treatment of prostate cancer (including locally confined inoperable disease that cannot be treated with definitive intent) and/or CRPC. Docetaxel administration in combination with androgen deprivation therapy (ADT) with or without next-generation AR-targeted therapy (abiraterone acetate, enzalutamide, or and next generation targeted agents Darolutamide, apalutamide) in metastatic hormone-sensitive disease is considered a prior docetaxel exposure.
- Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration.
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- Participant must be taking ADT with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤1.73 nmol/L (50 ng/dL) at the screening visit.
- Participant must be eligible for treatment with cabazitaxel per the locally approved prescribing information.
- ECOG PS grade of 0-2. ECOG PS 2 must be related to prostate cancer, not to other comorbidities.
- Estimated life expectancy of ≥6 months as assessed by the investigator.
- Participant has recovered from AEs (baseline or ≤ CTCAE Grade 1) due to prior anticancer therapy, unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator.
- Male participants are eligible to participate if they agree to the following during the intervention period and for at least 6 months after the last dose of study intervention:
- Must agree not to plan to father a child or donate sperm for the purpose of reproduction. PLUS, either of the following:
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Must agree to use contraception /barrier
- Participant with adequate hematologic, liver and renal function.
- Willing and able to adhere to the lifestyle restrictions specified in this protocol.
Who cannot join
- Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the IB), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Contraindications to the use of prednisone or medical ADT per locally approved prescribing information.
- Previous treatment with cabazitaxel in any setting.
- Had major surgical procedure or significant traumatic injury requiring general anaesthesia within 4 weeks or will not have fully recovered from surgical procedure prior to first dose of the study intervention; or has surgical procedure planned during the time the participant is expected to participate in the study.
- Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to >30% of bone marrow within 3 months prior to Baseline.
- Symptomatic peripheral neuropathy Grade ≥2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.5.0).
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- Presence of hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first dose of investigational intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention.
- Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.
- History of malignancy (except for prostate cancer) within the past 5 years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy.
- • Current or chronic history of liver disease. This includes [but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.
- Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Participant with clinically significant current or recent (within the past 3 months before randomization [unless otherwise specified below]) cardiac conditions.
- Known active CNS disease, except for treated stable asymptomatic CNS metastases.
- Known Leptomeningeal disease.
- Unmanageable concurrent bladder outflow obstruction or urinary incontinence.
- Has an active infection requiring systemic therapy.
- Spinal cord compression not definitively treated with surgical procedure and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥4 weeks prior to Baseline.
- Received an investigational intervention or used an invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer.
- Unable to swallow solid, oral dosage forms whole with the aid of water (participants cannot chew, divide, dissolve, or crush the investigational intervention) or and subjects with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
About this study
Official title: A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen
A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Read more
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.
- Being tested
- 50 mg cabazitaxel, 100 mg cabazitaxel, 200 mg cabazitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg cabazitaxelDrug
50 mg cabazitaxel to be taken every week for 6 cycles (3 doses per cycle), 10 mg prednisone to be taken daily till end of cycle 6
100 mg cabazitaxelDrug
100 mg cabazitaxel to be taken every week for 6 cycles (3 doses per cycle), 10 mg prednisone to be taken daily till end of cycle 6
200 mg cabazitaxelDrug
200 mg cabazitaxel to be taken every 3-week for 6 cycles (1 dose per cycle), 10 mg prednisone to be taken daily till end of cycle 6
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: 50 mg cabazitaxel |
| Arm 2 | Experimental | Not described Receives: Drug: 100 mg cabazitaxel |
| Arm 3 | Experimental | Not described Receives: Drug: 200 mg cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic progression-free survival (rPFS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer, MCRPCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jina Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890832
- Sponsor's protocol ID
- 0128-23
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen
- ClinicalTrials.gov ID
- NCT06890832
- Acronym / sponsor ID
- 0128-23
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Jina Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: 50 mg cabazitaxel |
| Arm 2 | Experimental | Drug: 100 mg cabazitaxel |
| Arm 3 | Experimental | Drug: 200 mg cabazitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study.
- Male participant ≥18 years of age at the time of signing the informed consent.
- Participant must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- Evidence of metastatic disease.
- Participant must be previously treated with a docetaxel-containing regimen (at least 3 cycles) for the treatment of prostate cancer (including locally confined inoperable disease that cannot be treated with definitive intent) and/or CRPC. Docetaxel administration in combination with androgen deprivation therapy (ADT) with or without next-generation AR-targeted therapy (abiraterone acetate, enzalutamide, or and next generation targeted agents Darolutamide, apalutamide) in metastatic hormone-sensitive disease is considered a prior docetaxel exposure.
Key exclusion criteria (21 listed)
- Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the IB), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
- Contraindications to the use of prednisone or medical ADT per locally approved prescribing information.
- Previous treatment with cabazitaxel in any setting.
- Had major surgical procedure or significant traumatic injury requiring general anaesthesia within 4 weeks or will not have fully recovered from surgical procedure prior to first dose of the study intervention; or has surgical procedure planned during the time the participant is expected to participate in the study.
- Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to >30% of bone marrow within 3 months prior to Baseline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50 mg cabazitaxel50 mg cabazitaxel to be taken every week for 6 cycles (3 doses per cycle), 10 mg prednisone to be taken daily till end of cycle 6 | Drug | Arm 1 |
| 100 mg cabazitaxel100 mg cabazitaxel to be taken every week for 6 cycles (3 doses per cycle), 10 mg prednisone to be taken daily till end of cycle 6 | Drug | Arm 2 |
| 200 mg cabazitaxel200 mg cabazitaxel to be taken every 3-week for 6 cycles (1 dose per cycle), 10 mg prednisone to be taken daily till end of cycle 6 | Drug | Arm 3 |
Primary outcome
Radiographic progression-free survival (rPFS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 50 mg cabazitaxel, 100 mg cabazitaxel and 200 mg cabazitaxel in people with Metastatic Castration-resistant Prostate Cancer, MCRPC, run by Jina Pharmaceuticals Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic progression-free survival (rPFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.