LUME-Ovar 1: Nintedanib (BIBF 1120) or Placebo in Combination With Paclitaxel and Carboplatin in First Line Treatment of Ovarian Cancer
Summary
The trial will be performed to evaluate if BIBF 1120 in combination with paclitaxel and carboplatin is more effective than placebo in combination with paclitaxel and carboplatin in first-line treatment of patients with advanced ovarian cancer. Safety information about BIBF1120/paclitaxel/carboplatin will be obtained.
Timeline
- Start
- 2009-11-17
- Primary completion
- 2013-04-01
- Completion
- 2016-09-15
Outcome
Met primary endpoint
registry analysis (superiority or other test); Nintedanib vs Placebo; p = 0.0239; Hazard Ratio (HR) 0.84 (95% CI 0.72 to 0.98); Log Rank NCT01015118 ↗
registry analysis (superiority or other test); Nintedanib vs Placebo; p = 0.0286; Hazard Ratio (HR) 0.86 (95% CI 0.75 to 0.98); Log Rank NCT01015118 ↗
paper Median progression-free survival was significantly longer in the nintedanib group than in the placebo group PMID 26590673 ↗
Publications
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
- du Bois A, Kristensen G, Ray-Coquard I, Reuss A, Pignata S, Colombo N, Denison U, Vergote I, Del Campo JM, Ottevanger P, Heubner M, Minarik T, Sevin E, de Gregorio N, Bidzinski M, Pfisterer J, Malander S, Hilpert F, Mirza MR, Scambia G, Meier W, Nicoletto MO, Bjorge L, Lortholary A, Sailer MO, Merger M, Harter P; AGO Study Group led Gynecologic Cancer Intergroup/European Network of Gynaecologic Oncology Trials Groups Intergroup Consortium. Standard first-line chemotherapy with or without nintedanib for advanced ovarian cancer (AGO-OVAR 12): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2016 Jan;17(1):78-89. doi: 10.1016/S1470-2045(15)00366-6. Epub 2015 Nov 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | 200 mg | — |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | — |