Clinical trial · Interventional
Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)
A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors
- 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 study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors. The corresponding primary hypotheses of this study are that 1) administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum of side effects observed in these participants after administration of oral MK-5108 alone and in combination with docetaxel will be dose-dependent and allow for definition of a maximum tolerated dose (MTD).
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 |
|---|---|---|---|
| Cancer, Neoplasms, Tumors | Malignant Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| MK-5108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (11)
- type
- EXPERIMENTAL
- label
- MK-5108 200 mg BID (Panel 1)
- description
- Participants receive 200 mg of MK-5108 orally twice daily (BID) the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
- interventionNames
- Drug: MK-5108
- type
- EXPERIMENTAL
- label
- MK-5108 400 mg BID (Panel 1)
- description
- Participants receive 400 mg of MK-5108 orally BID the first 2 days of a 14-day cycle (cycle extended to 21 days if ≥Grade 2 toxicity observed).
- interventionNames
- Drug: MK-5108
- type
- EXPERIMENTAL
- label
- MK-5108 800 mg BID (Panel 1)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy Exclusion Criteria: * Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier * Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent * Participant has received more than 2 courses of chemotherapy for metastatic disease * Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment * Participant has a primary central nervous system tumor * Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse * Participant is pregnant, breastfeeding or planning to have children during the study * Participant is Human Immunodeficiency Virus (HIV) positive * Participant has a history of Hepatitis B or C
References
Publications (1)
- RESULTAmin M, Minton SE, LoRusso PM, Krishnamurthi SS, Pickett CA, Lunceford J, Hille D, Mauro D, Stein MN, Wang-Gillam A, Trull L, Lockhart AC. A phase I study of MK-5108, an oral aurora a kinase inhibitor, administered both as monotherapy and in combination with docetaxel, in patients with advanced or refractory solid tumors. Invest New Drugs. 2016 Feb;34(1):84-95. doi: 10.1007/s10637-015-0306-7. Epub 2015 Dec 1. PMID 26620496