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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: Comparator: MK-8033

Drug: Comparator: MK-8033 +/- omeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559182

8033-001

2007_590

Details and patient eligibility

About

This is a first-in-human trial to establish the safety, tolerability, Recommended Phase II Dose (RP2D), pharmacodynamic, and clinical activity of MK-8033.

Parts A and B of the study will determine the maximum tolerated dose (MTD) and RP2D. Part C of the study will be a single panel crossover study to determine the effect of omeprazole, a gastric pH modifier, on the pharmacokinetics of MK-8033.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be at least 18 years of age, with adequate organ function, and an Eastern Cooperative Oncology Group (ECOG) performance of <2
Patient must be willing to undergo pre-study and post-dose tumor biopsy and have tumor accessible for biopsy (Waived during Parts A and C)

Exclusion criteria

Patient is currently using bisphosphonate therapy or has received this therapy in past 6 months
Patient has had chemotherapy, radiotherapy, or biological therapy within 4 weeks of study participation
Patient has history of cardiac disease
Patient with a primary central nervous system tumor
Patient has a known psychiatric or substance abuse disorder
Patient is pregnant or breastfeeding, or expecting to conceive during the study
Patient is known to be Human Immunodeficiency Virus (HIV) positive and the HIV infection is not well controlled
Patient has received therapy with a Proton-Pump Inhibitor, Histamine2-Receptor antagonist or antacid within one week of study participation (Part B only)