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

This study has been terminated.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01047007
First received: January 11, 2010
Last updated: June 23, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Solid Tumors
Drug: MK1775
Drug: Comparator: MK1775 in combination with 5-FU
Drug: Comparator: MK1775 in combination with 5-FU/CDDP
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Dose limiting toxicities [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Maximum Tolerated Dose of MK1775 in combination with 5-FU/CDDP, determined by number of dose limiting toxicities (DLTs) per dose level [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum Tolerated Dose of MK1775 in combination with 5-FU/CDDP, determined by number of dose limiting toxicities (DLTs) per dose level [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: January 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1
MK1775 monotherapy
Drug: MK1775
MK1775 capsule, dosage of 65 mg or 120 mg, orally twice daily on days 1-5 of a 21 day cycle.
Experimental: Part 2-A
MK1775 in combination with 5-FU
Drug: Comparator: MK1775 in combination with 5-FU
MK1775 capsule, dosage ranging from 20 mg to 200 mg, orally twice or once daily on Days 1-5 in a 21 day cycle. 5-Fluorouracil, from 1000 mg/m2/day to 750 mg/m2/day, intravenous infusion for 4 consecutive days starting on Day 1.
Experimental: Parts 2-B and 3
MK1775 in combination with 5-FU/CDDP
Drug: Comparator: MK1775 in combination with 5-FU/CDDP
MK1775 capsule, dosage ranging between 20 mg to 200 mg, orally twice or once daily on Days 1-5 in a 21day cycle; 5-Fluorouracil, from 1000 mg/m2/day to 750 mg/m2/day, intravenous infusion for 4 consecutive days starting on Day 1; Cisplatin, between 60 mg/m2 to 100 mg/m2, intravenous infusion on Day 1.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047007

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01047007     History of Changes
Other Study ID Numbers: 2010_503, MK1775-005
Study First Received: January 11, 2010
Last Updated: June 23, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
Head and Neck Cancer
Esophageal Cancer
Gastric Cancer

Additional relevant MeSH terms:
Neoplasms
Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014