NCT04556539

Brief Summary

A phase II, multicenter, open-label, single-arm study to evaluate the efficacy, safety and pharmacokinetics of SC10914 in subjects with gBRCA1/2 mutated advanced ovarian cancer in china.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 12, 2021

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 16, 2020

Last Update Submit

May 11, 2021

Conditions

Advanced Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • objective response rate (ORR)

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

    up to 100 weeks (estimated)

Study Arms (1)

SC10914 group

EXPERIMENTAL
Drug: SC10914

Interventions

SC10914DRUG

400mg TID, oral admination on fasting condition

SC10914 group

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sign informed consent voluntarily;
  • ≥18 years old;
  • Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma);
  • gBRCA1/2 mutation positive;
  • Had recived at least 2 prior lines of chemotherapy;
  • Platinum sensitive patients;
  • The last line of therapy befor enrollment failed；
  • ECOG≤2；
  • \. Had at least one measurable lesion.

You may not qualify if:

  • Any previous treatment with PARP inhibitor;
  • Symptomatic brain metastases;
  • Large amount of fluid in the third gap；
  • Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<100g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases) Cr \>1.5×ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Cancer Hospital

Fujian, China

RECRUITING

Central Study Contacts

Liu chunlei

CONTACT

13911737489liuchunlei@sh-qingfeng.net

Zhang zhe

CONTACT

13115039707zhangzhe@sh-qingfeng.net

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 21, 2020

Study Start

December 15, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

May 12, 2021

Record last verified: 2020-09

Locations

CN(1)