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:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01047007
First received: January 11, 2010
Last updated: June 23, 2011
Last verified: June 2011
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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:
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
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:
|
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 May 19, 2013