Phase 1
Completed N=27
Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)
Neoplasms · Malignant
Source: ClinicalTrials.gov NCT00880568 ↗
Enrolled (actual)
27
Serious AEs
25.9%
Results posted
Oct 2012
Primary outcomePrimary: Number of Participants With Dose-limiting Toxicities (DLTs) — 0; 0; 0; 0 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-limiting Toxicities (DLTs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Any Clinical or Laboratory Adverse Event |
3; 3; 2; 1; 3; 3 | — |
| SECONDARY Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle) |
305; 434; 295; 1460 | — |
| SECONDARY Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle) |
122; 302; 936; 2530; 2320 | — |
| SECONDARY Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle) |
141; 366; 1300; 3090; 3470 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00880568). 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.