Clinical trial · Interventional
A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients
A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
- 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)
This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.
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 |
|---|---|---|---|
| Relapsed Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib | Drug | — | UNRESOLVED |
| Fluzoparib+Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Safety Lead-in or Parallel, Fluzoparib+Apatinib
- description
- Participants will receive Fluzoparib-Apatinib combination until progression
- interventionNames
- Drug: Fluzoparib+Apatinib
- type
- ACTIVE_COMPARATOR
- label
- Fluzoparib monotherapy
- description
- Participants will receive Fluzoparib monotherapy until progression
- interventionNames
- Drug: Fluzoparib
- type
- OTHER
- label
- Exploratory cohort: Fluzoparib+Apatinib
- description
- Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically diagnosed high-grade serous or endometrioid recurrent ovarian,fallopian tube,or peritoneal cancer. 2. Patients must have received at least 2 previous platinum-containing regimens. 3. At least one target lesion. 4. ECOG performance status 0-1. 5. Adequate bone marrow, kidney and liver function. Exclusion Criteria: 1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib.For exploratory cohort ,patients who received PARP inhibitor are eligible; 2. Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed; 3. Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration; 4. Known to be human immunodeficiency virus positive; 5. Known active hepatitis C virus, or known active hepatitis B virus; 6. Untreated and/or uncontrolled brain metastases; 7. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration; 8. Pregnant or breast-feeding women.
References
Publications (0)
Data not yet available