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A Phase I Dose Escalation Study of MK-8033 in Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling
Advanced Cancer

Thank you

Trial Information

A Phase I Dose Escalation Study of MK-8033 in Patients With Advanced Solid Tumors

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of MK-8033 based on drug-related dose limiting toxicity.

Outcome Time Frame:

for the entire duration of study (27 months)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

July 2010

Related Keywords:

  • Advanced Cancer
  • Neoplasms