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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


Phase 1
20 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

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

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:

Dose limiting toxicities

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

2010_503

NCT ID:

NCT01047007

Start Date:

January 2010

Completion Date:

June 2011

Related Keywords:

  • Solid Tumors
  • Head and Neck Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Neoplasms

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