Clinical trial · Interventional
Study of SC10914 in Patients With gBRCA1/2 Mutation Advanced Ovarian Cancer
SC10914 Monotherapy for gBRCA1/2 Mutation Advanced Ovarian Cancer Patients With at Least 2 Prior Lines of Chemotherapy: a Single Arm, Open Label, Multicenter Clinical Trial
NCT04556539CI-TRIAL-00051764unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SC10914 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SC10914 group
- interventionNames
- Drug: SC10914
Primary outcomes (1)
- measure
- objective response rate (ORR)
- timeFrame
- up to 100 weeks (estimated)
- description
- assessed by the independent imaging assessment committee (recist1.1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign informed consent voluntarily; 2. ≥18 years old; 3. Histologically confirmed ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer( high-grade carcinoma cancer or endometrioid carcinoma); 4. gBRCA1/2 mutation positive; 5. Had recived at least 2 prior lines of chemotherapy; 6. Platinum sensitive patients; 7. The last line of therapy befor enrollment failed； 8. ECOG≤2； 8\. Had at least one measurable lesion. Exclusion Criteria: 1. Any previous treatment with PARP inhibitor; 2. Symptomatic brain metastases; 3. Large amount of fluid in the third gap； 4. 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
References
Publications (0)
Data not yet available
No reference posted for this study.