SC10914 Monotherapy for the mCRPC With g/s BRCA Mutation

NCT04486937 | Unknown Phase 1

• 1 other identifier: QF-SC10914-202
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, single arm phase I / II clinical study in mCRPC subjects who failed to receive docetaxel chemotherapy, abitolone acetate and / or enzalutamide (including its analogues) for the treatment of BRCA mutations in germ cells and / or somatic cells.

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  assessed by the independent imaging assessment committee (recist1.1)

  up to 100 weeks (estimated)

Secondary Outcomes (3)

• PFS

  up to 100 weeks (estimated)

• Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP)

  up to 100 weeks (estimated)

• overall survival (OS)

  up to 100 weeks (estimated)

Study Arms (1)

SC10914

EXPERIMENTAL

400mg TID，oral admination on an fasting state

Drug: S410914 tablet

Interventions

S410914 tablet DRUG

S410914 tablet

SC10914

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing informed consent voluntarily;
• Prostate cancer confirmed by histology or cytology;
• Metastatic lesions proved by imaging (CT / MRI / bone scan);
• At least one measurable lesion in accordance with recist1.1;
• deleterious or suspected deleterious germline and/or somatic BRCA-mutated (g/sBRCAm)
• ECOG≤2；
• The expected survival time was more than 3 months;
• Serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) at screening.
• Subjects without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) therapy throughout the duration of study treatment.
• Subjects must have progressed on prior NHA (e.g. abiraterone acetate and/or enzalutamide) for the treatment of mCRPC. 10.Subjects must have progressed on prior chemotherapy with docetaxel for the treatment of mCRPC.

You may not qualify if:

• Any previous treatment with PARP inhibitor
• Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks or 5 half-life.
• Subjects with known brain metastases.
• Major surgery within 2 weeks of starting study treatment and subjects must have recovered from any effects of any major surgery
• Subjects unable to swallow orally administered medication and subjects with gastrointestinal disorders likely to interfere with Absorption, distribution, metabolism and excretion of the study
• Immunocompromised subjects, e.g., subjects who are known to be serologically positive for human immunodeficiency virus (HIV)
• Subjects with a known hypersensitivity to SC10914 or any of the excipients of the product
• Subjects with known active hepatitis (i.e. Hepatitis B or C)
• Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria：
• ANC\<1.5×109/L；
• PLT\<100×109/L；
• Hb\<100g/L；
• TBIL\>1.5×ULN；
• ALT、AST\>2.5×ULN unless liver metastases are present in which case they must be \> 5×ULN；
• Cr \>1.5×ULN。

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Central Study Contacts

Yuping Zhang

CONTACT

18010196244; zhangyuping@sh-qingfeng.net

Wanwan Ji

CONTACT

18852605644; jiwanwan@sh-qingfeng.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 27, 2020
• Study Start: August 30, 2020
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share