Ph 1b Study to Evaluate GSK2110183 in Combination With Bortezomib and Dexamethasone in Subjects With Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Multiple Myeloma
Interventions
DRUG

GSK2110183

The oral, once daily dose of GSK2110183 will be dependent on the cohort to which a subject is assigned. Subjects enrolled in Cohort 1 will receive 75 mg GSK2110183 once daily. Dose escalation in Schedule A and Schedule B will follow 25 mg increments in a 3+3 dose escalation procedure up to a maximum of 150mg daily or until MTD is reached, whichever comes first, for each schedule. GSK2110183 will continue at daily dosing until treatment discontinuation criteria is met.

DRUG

Bortezomib

Bortezomib (1.0 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for cohort 1 for up to 8 cycles. Bortezomib (1.3 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Bortezomib (1.5 mg/m2) will be administered on days 1, 8, and 15 of each 21-day cycle for up to 8 cycles.

DRUG

Dexamethasone

Dexamethasone will be given orally at a fixed dose of 20 mg only on days of bortezomib dosing in both Schedule A and Schedule B.

Trial Locations (13)

100

Novartis Investigative Site, Taipei

3004

Novartis Investigative Site, Melbourne

10029

Novartis Investigative Site, New York

30322

Novartis Investigative Site, Atlanta

43210

Novartis Investigative Site, Columbus

53792

Novartis Investigative Site, Madison

60637

Novartis Investigative Site, Chicago

85259

Novartis Investigative Site, Scottsdale

91010

Novartis Investigative Site, Duarte

27599-7305

Novartis Investigative Site, Chapel Hill

V5Z 1M9

Novartis Investigative Site, Vancouver

M5G 2M9

Novartis Investigative Site, Toronto

Unknown

Novartis Investigative Site, Galway

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY