Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

June 9, 2017

Study Completion Date

December 31, 2017

Conditions
Solid Tumors
Interventions
DRUG

BKM120-CIS

"BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Cisplatin will be delivered intravenously at the dose of 75 mg/m2 on day 1 every 3 weeks at each dose level of BKM120.~In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity"

DRUG

BKM120-CARBO

"BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Carboplatin will be delivered intravenously at AUC 5 on day 1 every 3 weeks at each dose level of BKM120. Should dose level 3 be completed, carboplatin will be given at AUC 6 and BKM120 at 100 mg.~In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity"

Trial Locations (1)

20100

Ospedale San Raffaele, Milan

All Listed Sponsors
lead

Fondazione Michelangelo

OTHER

NCT02439489 - Study of the Combination of BKM120 and Cisplatin or Carboplatin in Patients With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter