A Phase I Dose Escalation Study of MK1775 in Monotherapy, in Combination With 5-Fluorouracil, and in Combination With 5-Fluorouracil and Cisplatin in Patients With Advanced Solid Tumor
Inclusion Criteria:
- Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed
locally advanced or metastatic solid tumor failed to respond to standard therapy,
progressed despite standard therapy, or for which standard therapy does not exist
- Parts 2-B and 3: Patient must have a histologically or cytologically confirmed
locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a
candidate of 5-Fluorouracil and Cisplatin regimen defined in this study
- Patient must have performance status of 0 or 1 on the ECOG Performance Scale
Exclusion Criteria:
- Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks
(6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or
who has not recovered from adverse events due to agents administered more than 4
weeks earlier
- Patient with a known primary central nervous system tumor
- Patient has known hypersensitivity to any of the components of the combination study
therapy or its analogs
- Patient is receiving "alternative" cancer medications such as plant-derived products
and their analogs with anti-tumor activity within 1 week prior to entering the study.
- Patient must not have prior radiation therapy to more than 30% of the bone marrow and
must have recovered for at least 3 weeks from the hematologic toxicity of prior
radiotherapy