Phase 1
Completed N=35
Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)
Cancer, Neoplasms, Tumors
Source: ClinicalTrials.gov NCT00543387 ↗
Enrolled (actual)
35
Serious AEs
30.8%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event (AE) — 3; 3; 3; 3 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
3; 3; 3; 3; 3; 3 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00543387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.