Clinical trial · Interventional
A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC
A Phase II Clinical Study of SHR3680 Combined With SHR3162 in the Treatment of Metastatic Castration-resistant Prostate Cancer Previously Treated With Abiraterone and Docetaxel
NCT04102124CI-TRIAL-00091279terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The sponsor's R\&D strategy is adjusted.
Summary
Brief summary (as posted)
The aim of this trial is to evaluate SHR3680 combined with SHR3162 and SHR3680 single drug to improve Metastatic Castration Resistant Prostate Cancer Patients whether the patient's overall survival (OS) is superior to placebo.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR3162 | Drug | — | UNRESOLVED |
| SHR3162(Placebo) | Drug | — | UNRESOLVED |
| SHR3680 | Drug | — | UNRESOLVED |
| SHR3680(Placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- SHR3680+SHR3162
- description
- Participants will receive SHR3680 combined with SHR3162 orally
- interventionNames
- Drug: SHR3680
- Drug: SHR3162
- type
- EXPERIMENTAL
- label
- SHR3680+SHR3162(Placebo)
- description
- Participants will receive SHR3680 combined with SHR3162(Placebo) orally
- interventionNames
- Drug: SHR3680
- Drug: SHR3162(Placebo)
- type
- PLACEBO_COMPARATOR
- label
- SHR3680(Placebo)+SHR3162(Placebo)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed prostate cancer; does not suggest neuroendocrine or small cell characteristics 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1; 3. Radiographic evidence of metastasis; 4. Sustained therapy of luteinizing hormone-releasing hormone analogue(LHRHA)or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of LHRHA; 5. Evidence of prostate cancer progression under the sustained therapy of LHRHA or bilateral orchiectomy; 6. Adequate hepatic, renal, heart, and hematological functions; 7. Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 8. Patient has been treated with Abiraterone and treatment failed(Treatment failure is defined as the progression of disease during treatment) 9. Patient has been treated with Docetaxel and treatment failed or can not tolerate docetaxel chemotherapy or patients who are not suitable for docetaxel treatment at the time of screening. Exclusion Criteria: 1. Have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immuntherapy, and endocrinotherapy; 2. Planned to initiate any other anti-tumor therapies during the study; 3. Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; 4. Clinically significant cardiovascular diseases; 5. History of seizure or certain conditions that may predispose to seizure; 6. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.