A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

December 5, 2007

Primary Completion Date

June 10, 2010

Study Completion Date

July 9, 2010

Conditions
Advanced Cancer
Interventions
DRUG

Comparator: MK-8033

"MK-8033 will be administered as an oral formulation in sequentially rising dose levels starting at 50 mg and continuing at 100% dose increments until dose level 4 (800 mg total daily dose). Dose levels 5 to 11 will be escalated at \~40% dose increments until 3000mg (total daily dose). The daily dose of MK-8033 will be divided into two equal doses. MK-8033 will be administered in a first cycle of 14 days (continuous drug administration from Day 1 through Day 14), followed by a 1 week drug holiday (Cycle 1, Day 15 through Day 21). Subsequent cycles of MK-8033 will be administered for 14 days (Cycles 2 to 4) and 28 days (Cycle 5 and beyond).~Enrollment in Parts A and B has been completed."

DRUG

Comparator: MK-8033 +/- omeprazole

"Part C will occur at only one of the investigational sites.~In Cycle 1, patients will be randomized to one of two treatment sequences, A/B or B/A, over two treatment periods. Treatment A: 770 mg MK-8033 twice daily with co-administration of 20 mg omeprazole once daily. Treatment B: 770 mg MK-8033 twice daily. After Cycle 1 is complete, patients may continue to receive MK-8033 until disease progression or unacceptable toxicity.~Enrollment for Part C has been suspended."

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00559182 - A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001) | Biotech Hunter | Biotech Hunter