Clinical trial · Interventional
A Study of MK-8033 in Patients With Advanced Solid Tumors (MK-8033-001)
A Phase I Dose Escalation Study of MK-8033 in Patients With Advanced Solid Tumors
NCT00559182CI-TRIAL-00059888completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: MK-8033 | Drug | — | UNRESOLVED |
| Comparator: MK-8033 +/- omeprazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Parts A and B: MK-8033
- description
- Dose Escalation Study
- interventionNames
- Drug: Comparator: MK-8033
- type
- EXPERIMENTAL
- label
- Part C: MK-8033 +/- omeprazole
- description
- Crossover Study
- interventionNames
- Drug: Comparator: MK-8033 +/- omeprazole
Primary outcomes (8)
- measure
- Safety and tolerability of MK-8033 based on drug-related dose limiting toxicity.
- timeFrame
- for the entire duration of study (27 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- RESULTKeedy VL, Lenz HJ, Saltz L, Whisenant JG, Berlin JD, Camacho LH. First-in-human phase I dose escalation study of MK-8033 in patients with advanced solid tumors. Invest New Drugs. 2018 Oct;36(5):860-868. doi: 10.1007/s10637-018-0567-z. Epub 2018 Jan 29. PMID 29376210