drugset / Trial / NCT01297452
BKM120 + Carboplatin + Paclitaxel for Patients With Advanced Solid Tumors
Phase 1
Completed
45 enrolled
Memorial Sloan Kettering Cancer Center
Novartis Pharmaceuticals · collabSai Life Sciences · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to find out the good and bad effects that occur when BKM120 is added to standard chemotherapy with carboplatin and paclitaxel.
Timeline
- Start
- 2011-02-15
- Primary completion
- 2017-03-29
- Completion
- 2017-03-29
Publications
- Smyth LM, Monson KR, Jhaveri K, Drilon A, Li BT, Abida W, Iyer G, Gerecitano JF, Gounder M, Harding JJ, Voss MH, Makker V, Ho AL, Razavi P, Iasonos A, Bialer P, Lacouture ME, Teitcher JB, Erinjeri JP, Katabi N, Fury MG, Hyman DM. A phase 1b dose expansion study of the pan-class I PI3K inhibitor buparlisib (BKM120) plus carboplatin and paclitaxel in PTEN deficient tumors and with dose intensified carboplatin and paclitaxel. Invest New Drugs. 2017 Dec;35(6):742-750. doi: 10.1007/s10637-017-0445-0. Epub 2017 Mar 9.
- Hyman DM, Snyder AE, Carvajal RD, Gerecitano JF, Voss MH, Ho AL, Konner J, Winkelmann JL, Stasi MA, Monson KR, Iasonos A, Spriggs DR, Bialer P, Lacouture ME, Teitcher JB, Katabi N, Fury MG. Parallel phase Ib studies of two schedules of buparlisib (BKM120) plus carboplatin and paclitaxel (q21 days or q28 days) for patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Apr;75(4):747-55. doi: 10.1007/s00280-015-2693-z. Epub 2015 Feb 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buparlisib | Small molecule | 50 mg | Oral |
| Subject | Buparlisib | Small molecule | 80 mg | Oral |
| Subject | Buparlisib | Small molecule | 100 mg | Oral |
| Subject | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Subject | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |