A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
18 Years
N/A
Both
Neoplasms, Malignant
Trial Information
A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Dose-limiting Toxicities (DLTs)
Outcome Description:
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
Outcome Time Frame:
Cycle 1 (up to 21 or 28 days, depending on treatment arm)
Safety Issue:
Yes
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
MK-1496-002
NCT ID:
NCT00880568
Start Date:
April 2009
Completion Date:
January 2011
Related Keywords:
- Neoplasms
- Malignant
- Neoplasms
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