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A Dose Escalation Study of MK1775 in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Solid Tumors

Intervention: MK1775 (Drug); Comparator: MK1775 in combination with 5-FU (Drug); Comparator: MK1775 in combination with 5-FU/CDDP (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

Summary

The study evaluates safety of MK1775 in monotherapy, and in combination with 5-FU alone or with 5-FU/CDDP in Japanese patients with solid tumor

Clinical Details

Official title: 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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Dose limiting toxicities

Maximum Tolerated Dose of MK1775 in combination with 5-FU/CDDP, determined by number of dose limiting toxicities (DLTs) per dose level

Secondary outcome: Maximum Tolerated Dose of MK1775 in combination with 5-FU/CDDP, determined by number of dose limiting toxicities (DLTs) per dose level

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: January 2010
Last updated: February 3, 2015

Page last updated: August 20, 2015

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