Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Apatinib

Abiraterone Acetate

Prednisone

Fluzoparib

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protein Kinase Inhibitors

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Fluzoparib Orally twice daily（Cohort 1、Cohort 4）

Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）

Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets

Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3、Cohort 4）

Fluzoparib Combined With Apatinib

Main research purpose: To evaluate the effectiveness of Fluzoparib combined with apatinib mesylate in the treatment of patients with metastatic castration-resistant prostate cancer.

Fluzopali in combination with apatinib mesylate or fluzopali monotherapy with or without homologous recombinant repair-related gene mutations in metastatic castration-resistant prostate in subjects

A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer

An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer

Comprehensive remission rate means the proportion of objective remission or PSA remission evaluated by the investigator based on the RECIST v1.1 standard and the PCWG3 standard

The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.

ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)).

PSA response rate was Defined as the proportion of subjects whose serum PSA level decreased by ≥50% from baseline after treatment.

PSA-TTP was defined as the time from random (cohort 1 and 4) or first medication (cohort 2 and 3) to the first progression of PSA; PSA progression is determined according to the PCWG3 standard, and changes in PSA levels within the 12 weeks before treatment (that is, before C4D1) are not included in this Evaluation.

Number of Participants with Overall Survival (OS)

Jiangsu HengRui Medicine Co., Ltd.

Fluzoparib in the initial dose of 40mg.bid started into the group of participants, group A combined with a fixed dose of Apatinib 250mg.qd for treatment, followed by the 40mg.bid, 60mg.bid, 80mg.bid, 100mg.bid dose increase.

Fluzoparib in the initial dose of 40mg.bid started into the group of participants, Group B was treated with a fixed dose of Apatinib 500mg.qd, followed by an increase in doses of 40mg.bid, 60mg.bid, 80mg.bid, 100mg.bid .

Fluzoparib :

40mg.bid, morning and evening each time, interval of 12 hours or so, the first oral administration 72 hours later

Apatinib :

250mg or 500mg take one day, 72 hours later, the continuous drug delivery phase (B-C1D1) was entered into the Fluzoparib, that is, the Fluzoparib capsule with 40mg.bid, every morning and evening, each time, interval of 12 hours, the Apatinib tablets daily with the Fluzoparib capsule with the same service, fixed doses of 250mg or 500mg, daily. Continuous drug delivery for 28 days for one cycle

Fluzoparib combined with Apatinib

Haitao Wang, Ph.D

Assessment of the safety and tolerability of Fluzoparib combined with Apatinib in the treatment of advanced refractory solid tumors with TP53 harmful mutations.

Results of the clinical trial of the combination of Fluzoparib and Apatinib in the treatment of gastric cancer animal model and the drug PARP inhibitor alone, PARP inhibitor combined with VEGFR inhibitor, Patients with advanced refractory solid tumors with TP53 harmful mutations can be expected to be safe and effective in the treatment of Fluzoparib and Apatinib.

Treatment of Carrying TP53 Harmful Mutations

Fluzoparib Combined With Apatinib for the Treatment of Carrying TP53 Harmful Mutations in Advanced Refractory Solid Tumors of the I Stage Clinical Study

provide right dosage for II phase clinical trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer	NCT04869488	Metastatic Cast...	Fluzoparib Enzalutamide OR... Fluzoparib Comb...	18 Years -	Jiangsu HengRui Medicine Co., Ltd.
Treatment of Carrying TP53 Harmful Mutations	NCT03645200	Advanced Cancer	Fluzoparib comb...	18 Years - 70 Years	Tianjin Medical University Second Hospital

Spots Global Cancer Trial Database for fluzoparib combined with apatinib