drugset / Trial / NCT02866370
Study Of Nintedanib Compared To Chemotherapy in Patients With Recurrent Clear Cell Carcinoma Of The Ovary Or Endometrium
Phase 2
Unknown
120 enrolled
NHS Greater Glasgow and Clyde
ARCAGY/ GINECO GROUP · collabBoehringer Ingelheim · collabCancer Research UK · collabEuropean Organisation for Research and Treatment of Cancer - EORTC · collabNordic Society of Gynaecological Oncology - Clinical Trials Unit · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The trial will recruit up to 120 patients; 90 with ovarian clear cell carcinoma and up to 30 with endometrial clear cell carcinoma. Patients will be randomised between chemotherapy and Nintedanib 200mg twice daily oral administration (PO) continuously. The primary diagnosis must be histologically confirmed and central pathological review of the presenting tumour or biopsy of relapsed disease must find at least 50% clear cell carcinoma with no serous differentiation
Timeline
- Start
- 2015-04
- Primary completion
- 2020-03
- Completion
- 2021-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 40 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Nintedanib | Small molecule | 200 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Comparator | Topotecan | Small molecule | 4 mg/m2 | Intravenous |