Clinical trial · Interventional
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
NCT00880568CI-TRIAL-00016895completedPhase 1Results postedClinicalTrials.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 study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-1496 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (9)
- type
- EXPERIMENTAL
- label
- MK-1496 20 mg (21-Day Cycle)
- description
- Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
- interventionNames
- Drug: MK-1496
- type
- EXPERIMENTAL
- label
- MK-1496 40 mg (21-Day Cycle)
- description
- Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
- interventionNames
- Drug: MK-1496
- type
- EXPERIMENTAL
- label
- MK-1496 80 mg (21-Day Cycle)
- description
- Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. * Participant must have Performance Status 0 or 1. * Participant must have adequate organ function. Exclusion Criteria * Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration. * Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen). * Participant has known hypersensitivity to the components of study drug or its analogs. * Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.
References
Publications (0)
Data not yet available
No reference posted for this study.