Clinical trial · Interventional
Dose Escalation Study of BIBF 1120 in Combination With Carboplatin and PLD in Relapsed Ovarian Cancer (OC)
An Open-label, Dose Escalation Phase I Study of the Safety and Tolerability of BIBF 1120 in Combination With Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Japanese Patients With a First, Second or Third Platinum-sensitive Relapse of Advanced Epithelial Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer.
- 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 phase I, open label dose escalation study will investigate the addition of BIBF 1120 to treatment with the combination of carboplatin and Pegylated Liposomal Doxorubicin (PLD) in patients with advanced, platinum sensitive relapsed ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer. Patients will be treated with BIBF 1120 together with carboplatin and PLD in up to 6-9 repeated 28 days treatment courses until disease progression is observed.
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 |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min | Drug | — | UNRESOLVED |
| BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min | Drug | — | UNRESOLVED |
| BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- BIBF 1120 (low) + Carboplatin + PLD
- description
- BIBF 1120 (low dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)
- interventionNames
- Drug: BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
- type
- EXPERIMENTAL
- label
- BIBF 1120 (medium) + Carboplatin + PLD
- description
- BIBF 1120 (medium dose) + carboplatin (AUC5 mg/mL\*min) + PLD (30 mg/m2)
- interventionNames
- Drug: BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min
- type
- EXPERIMENTAL
- label
- BIBF 1120 (high) + Carboplatin + PLD
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria: 1. Female patients, age 20 years or older, with relapse of histologically (on initial diagnosis) confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer 2. Up to 3 lines of prior chemo therapy, with treatment free interval of \>6 months 3. Platinum based chemotherapy in the immediately preceding line. 4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 5. Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines Exclusion criteria: 1. Prior chemotherapy with PLD, and any contraindication for therapy with carboplatin or PLD. 2. More than 2 lines of prior therapies that contained angiogenesis inhibitor. 3. Patients for whom surgery is planned, e.g. interval debulking surgery. 4. History of a cerebral vascular accident, transient ischemic attack or subarachnoid haemorrhage within the past 6 months. 5. Serious infections in particular if requiring systemic antibiotic (antimicrobial, antifungal) or antiviral therapy. 6. Laboratory values indicating an increased risk for adverse events. 7. Significant cardiovascular diseases.
References
Publications (0)
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