This is a phase 2 Study to Investigate Efficacy and Safety of Different Dose Regimen of Cabazitaxel Lipid Tablet in Adult Participants with Prostate Cancer

Phase 2

Conditions: Health Condition 1: Z191- Hormone sensitive malignancy status

Registration Number: CTRI/2024/04/066247

Lead Sponsor: Intas Pharmaceuticals Ltd., India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

(1)Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study.

(2)Male participant greater 18 years of age at the time of signing the informed consent.

(3)Participant must have histological pathological, and/or cytological confirmation of adenocarcinoma of the prostate (Patient presenting with focal neuroendocrine differentiation or treatment emergent neuroendocrine differentiation, but not primary small cell features, are eligible). Diagnosis must be stated in a pathology report and confirmed by the investigator.

(4)Evidence of metastatic disease (as defined by AJCC 8th edition criteria) on previous bone, CT, and/or MRI scan. Metastatic disease is defined as at least one documented metastatic lesion on either bone scan or CT/MRI scan. Subjects whose disease spread is limited to regional lymph nodes per AJCC or local recurrence (e.g., bladder, rectum) are not eligible.

(5)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.

(6)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. Disease progression for study entry is defined as one or more of the following three criteria as determined by the investigator: PSA progression as demonstrated by rising PSA levels: Rising PSA is defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. The third (or the fourth) confirmatory PSA should be taken within 4 weeks prior to randomization. The third (or the fourth) confirmatory PSA must be greater than or equal to 2.0 ng/mL (1.0 ng/mL if confirmed rise in PSA is the only indication of progression). Early PSA level (within 12 weeks) increase should not be considered as progression. Participants who received a first-generation anti-androgen must have progression after withdrawal (greater than or equal to 6 weeks since last bicalutamide or nilutamide administration; greater than or equal to 4 weeks since last flutamide, megestrol acetate and any other hormonal therapy administration). Radiographic disease progression in soft tissue based on RECIST 1.1 criteria. Previously normal (less than 1.0 cm) lymph nodes must have grown by greater than or equal to 5 mm in the short axis to be considered to have pr

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from participating in the study:

(1) 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.

(2) Contraindications to the use of prednisone or medical ADT per locally approved prescribing information. Note: Applicable only if patient is receiving medical ADT. (3) Previous treatment with cabazitaxel in any setting.

(4) 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. NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator.

(5) Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to greater than 30percent of bone marrow within 3 months prior to Baseline.

(6) Symptomatic peripheral neuropathy Grade greater than or equal to 2 (National Cancer Institute Common Terminology Criteria [NCI CTCAE] v.5.0).

(7) Presence of hepatitis B surface antigen (HbsAg) at screening or within 3 months prior to first dose of investigational intervention.

(8) Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.

(9) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening. For participants with unknown HIV status, HIV testing will be performed at screening unless prohibited by local regulations.

(10) 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. NOTE: The time requirement for no evidence of disease for at least 3 years does not apply to the (except for prostate cancer) for which a participant is enrolled in the study. The time requirement also does not apply to participants basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers who underwent successful definitive resection with no evidence of metastatic disease which is considered cured with minimal risk of recurrence.

(11) 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, Wilsons disease, alpha1 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint will be Radiographic progression-free survival (rPFS).Timepoint: the time from date of randomization or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
All secondary endpoints will be evaluated statistically, as appropriateTimepoint: the time from the date of randomization to date of death due to any cause.