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

January 11, 2010
June 23, 2011
January 2010
June 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01047007 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Dose Escalation Study of MK1775 in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005)
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
  • Drug: MK1775
    MK1775 capsule, dosage of 65 mg or 120 mg, orally twice daily on days 1-5 of a 21 day cycle.
  • 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.
  • 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.
  • Experimental: Part 1
    MK1775 monotherapy
    Intervention: Drug: MK1775
  • Experimental: Part 2-A
    MK1775 in combination with 5-FU
    Intervention: Drug: Comparator: MK1775 in combination with 5-FU
  • Experimental: Parts 2-B and 3
    MK1775 in combination with 5-FU/CDDP
    Intervention: Drug: Comparator: MK1775 in combination with 5-FU/CDDP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01047007
2010_503, MK1775-005
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP