Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-5108 · 1 trial · 1 indication
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported for each dose level group.
DLTs were AEs considered related to study drug that prevented escalation of the drug dose. Hematologic DLTs included any Grade 5 hematologic toxicity, Grade 4 neutropenia lasting for ≥7 days in duration, Grade 3 or Grade 4 neutropenia with fever \>38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and Grade 4 thrombocytopenia (≤25.0 x 10\^9/L). Non-hematologic DLT was defined as any Grade 3, 4, or 5 non-hematologic toxicity, with the specific exceptions of: Grade 3 nausea or Grade 3 vomiting, Grade 3 diarrhea, or Grade 3 dehydration occurring in the setting of inadequate compliance with supportive care and lasting for \<48 hours, alopecia, inadequately treated hypersensitivity reactions, or Grade 3 elevated transaminases of ≤1 week in duration. Any drug-related AE leading to a dose modification of MK-5108, or any unresolved drug-related toxicity persisting\>6 weeks, was also considered a DLT.
| Arm | Type | Description |
|---|---|---|
| MK-5108 200 mg BID (Panel 1) | EXPERIMENTAL | 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). |
| MK-5108 400 mg BID (Panel 1) | EXPERIMENTAL | 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). |
| MK-5108 800 mg BID (Panel 1) | EXPERIMENTAL | Participants receive 800 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). |
| MK-5108 1200 mg BID (Panel 1) | EXPERIMENTAL | Participants receive 1200 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). |
| MK-5108 1500 mg BID (Panel 1) | EXPERIMENTAL | Participants receive 1500 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). |
| MK-5108 1800 mg BID (Panel 1) | EXPERIMENTAL | Participants receive 1800 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). |
| MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Panel 2) | EXPERIMENTAL | Participants receive 100 mg of MK-5108 orally BID in combination with 60 mg/m\^2 Docetaxel administered intravenously (IV) the first 2 days of a 21-day cycle. |
| MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Panel 2) | EXPERIMENTAL | Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m\^2 Docetaxel administered IV the first 2 days of a 21-day cycle. |
| MK-5108 225 mg BID + 60 mg/m^2 Docetaxel (Panel 2) | EXPERIMENTAL | Participants receive 150 mg of MK-5108 orally BID in combination with 60 mg/m\^2 Docetaxel administered IV the first 2 days of a 21-day cycle. |
| MK-5108 100 mg BID + 60 mg/m^2 Docetaxel (Crossover) | EXPERIMENTAL | After receiving treatment in Panel 1, one participant crossed over to Panel 2 per protocol following disease progression to receive 100 mg of MK-5108 orally BID in combination with 60 mg/m\^2 Docetaxel administered IV the first 2 days of a 21-day cycle. |
| MK-5108 150 mg BID + 60 mg/m^2 Docetaxel (Crossover) | EXPERIMENTAL | After receiving treatment in Panel 1, participants crossed over to Panel 2 per protocol following disease progression to receive 150 mg of MK-5108 orally BID in combination with 60 mg/m\^2 Docetaxel administered IV the first 2 days of a 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| MK-5108 | DRUG | MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2. |
| docetaxel | DRUG | Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m\^2 Q12H during the first 2 days of each 21-day cycle. |
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...
MK-5108 is an investigational small molecule being developed for the treatment of cancer, neoplasms, and tumors. It is an oncology therapy that has been studied in patients with advanced and/or refractory solid tumors. The drug is currently in clinical development and has not been approved by regulatory authorities.
MK-5108 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company conducted a Phase 1 clinical trial of MK-5108 in patients with advanced solid tumors. Merck is a major pharmaceutical company with a significant presence in oncology research.
MK-5108 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available as a marketed therapy. Further clinical studies would be needed to advance the drug through later phases of development.
MK-5108 has been studied in one completed clinical trial, identified as NCT00543387. This Phase 1 study, titled "Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)," enrolled 35 participants aged 18 years and older. The trial was a controlled, randomized study that has been completed.
MK-5108 is a unique investigational compound developed by Merck & Company, Inc. It is not known to be marketed under any other name. The drug is a small molecule being studied for its potential use in oncology, specifically for the treatment of advanced solid tumors.