NCT06099990Not yet recruitingPhase 1
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)
A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of 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).
Source: ClinicalTrials.gov · Last updated 25 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 660 (estimated)
- First submitted
- 13 Oct 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT06099990
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 660
- From 1 Oct 2023 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ADT, chemotherapy, surgery, external radiation exposure, brachytherapy, radiopharmaceuticals, or experimental topical treatments (eg, radiofrequency ablation, cryoponic, high-energy focused ultrasound) for prostate cancer
- 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
- Plan to receive any other antitumor therapy during this trial
- Inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect drug taking and absorption
Other illness
- History of severe lung disease such as interstitial pneumonia
Other
- Confirmed by imaging, there are brain tumor foci
Who the study is looking for
- Age of ≥ 18 years old,male
- ECOG PS score of 0 or 1；
- Prostate adenocarcinoma confirmed by histological。
- ADT no more than 3 months prior to randomization (when docetaxel is not used) with no radiographic or PSA progression
- 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)
- Voluntarily participate in this clinical trial, understand the study procedure and have signed informed consent
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.