Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

NCT ID: NCT06099990

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2028-12-31

Brief Summary

This study was to evaluate the safety and efficacy of dalcilide tablets in combination with AA-P in the treatment of subjects with high tumor burden mHSPC and to determine the second stage starting dose and progression-free survival（rPFS） based on BICR assessment

Conditions

High-volume, Metastatic, Hormone-sensitive Prostate Cancer (mHSPC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

dalpiciclib+ abiraterone+ prednisone

Group Type: EXPERIMENTAL

dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets

Intervention Type: DRUG

dalpiciclib+ abiraterone+ prednisone

placebo+abirarerone+prenisone

Group Type: PLACEBO_COMPARATOR

placebo; abiraterone acetate tablets; prednisone tablets

Intervention Type: DRUG

placebo+abirarerone+prenisone

Interventions

dalpiciclib isethionate tablets; abiraterone acetate tablets; prednisone tablets

dalpiciclib+ abiraterone+ prednisone

Intervention Type: DRUG

placebo; abiraterone acetate tablets; prednisone tablets

placebo+abirarerone+prenisone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age of ≥ 18 years old,male

2. ECOG PS score of 0 or 1；

3. Prostate adenocarcinoma confirmed by histological。

4. ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression

5. Receiving or maintaining androgen deprivation therapy (ADT) during the planned study period, i.e. continuous treatment with luteinizing hormone-releasing hormone analogues (LHRHA) (drug castration) or prior bilateral orchiectomy (surgical castration)

6. Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent

Exclusion Criteria

1. Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer

2. Previous use of CDK4/6 inhibitors (such as piperaciclib, rebocillib and abeceptil), second-generation androgen receptor antagonists (such as enzalutamide, apatamide, darotamide, revilumide and proclomide, etc.), ketoconazole, abiraterone acetate or other investigational drugs that inhibit androgen synthesis (such as TAK-700), other anti-tumor biological therapy, targeted therapy or tumor immunotherapy

3. Confirmed by imaging, there are brain tumor foci

4. History of severe lung disease such as interstitial pneumonia

5. Plan to receive any other antitumor therapy during this trial

6. Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Feng Liu

Role: CONTACT

feng.liu.fl10@hengrui.com

+86-18875033874

Other Identifiers

SHR6390-305

Identifier Type: -

Identifier Source: org_study_id