A Study of SCH 717454 in Combination With Different Treatment Regimens in Pediatric Subjects With Advanced Solid Tumors (Study P05883)
Overview[ - collapse ][ - ]
Purpose | Hypothesis: SCH 717454 can be safely administered in combination with chemotherapy regimens in pediatric subjects. This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of SCH 717454 administered in combination with chemotherapy in pediatric subjects with solid tumors, to be conducted in conformance with Good Clinical Practices. This study has three independent arms that consist of an evaluation of the safety, tolerability, and dose-finding of SCH 717454 when administered in combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and vincristine (Arm B), or ifosfamide and etoposide (Arm C). |
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Condition | Neoplasms Solid Tumors Bone Cancer Kidney Tumor Neuroblastoma |
Intervention | Drug: Temozolomide, Irinotecan, and SCH 717454 Drug: Vincristine, Doxorubicin, Cyclophosphamide (CAV), and SCH 717454 Drug: Ifosfamide, Etoposide (IE), and SCH 717454 |
Phase | Phase 1 |
Sponsor | Merck Sharp & Dohme Corp. |
Responsible Party | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier | NCT00960063 |
First Received | August 14, 2009 |
Last Updated | January 30, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | August 14, 2009 |
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Last Updated Date | January 30, 2014 |
Start Date | November 2009 |
Estimated Primary Completion Date | December 2010 |
Current Primary Outcome Measures | All Dose Limiting Toxicities tabulated by treatment arm and dose level [Time Frame: From beginning of treatment to approximately 30 days after the final dose of SCH 717454 or the standard treatment assigned (whichever is last). Data will be collected at all visits.] [Designated as safety issue: Yes] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | A Study of SCH 717454 in Combination With Different Treatment Regimens in Pediatric Subjects With Advanced Solid Tumors (Study P05883) |
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Official Title | A Phase 1/1B Dose-Escalation Study to Determine the Safety and Tolerability of SCH 717454 Administered in Combination With Chemotherapy in Pediatric Subjects With Advanced Solid Tumors P05883 |
Brief Summary | Hypothesis: SCH 717454 can be safely administered in combination with chemotherapy regimens in pediatric subjects. This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of SCH 717454 administered in combination with chemotherapy in pediatric subjects with solid tumors, to be conducted in conformance with Good Clinical Practices. This study has three independent arms that consist of an evaluation of the safety, tolerability, and dose-finding of SCH 717454 when administered in combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and vincristine (Arm B), or ifosfamide and etoposide (Arm C). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Temozolomide, Irinotecan, and SCH 717454 Temozolomide 100 mg/m2/day on Days 1-5; and irinotecan 10 mg/m2/day IV on Days 1-5 and Days 8-12 and SCH 717454 on Day 1. Drug: Vincristine, Doxorubicin, Cyclophosphamide (CAV), and SCH 717454 Vincristine 2 mg/m2 (max 2mg) on Day 1; Cyclophosphamide 1200 mg/m2 IV on Day 1, Doxorubicin hydrochloride 75 mg/m2 IV continuously over 48 hours (dactinomycin 1.25 mg/m2 can be substituted for doxorubicin after Cycle 1, when a total doxorubicin dose of 450 mg/m2 is reached). SCH 717454 on Day 1 Subjects with high risk Ewing's sarcoma may be enrolled on Arm B on a case-by-case basis, and if they tolerate the combination during the first cycle, may then be treated with alternating cycles of treatment of CAV and ifosfamide/etoposide (IE) in combination with SCH 717454. Drug: Ifosfamide, Etoposide (IE), and SCH 717454 Ifosfamide 1800 mg/m2 per day IV and etoposide 100 mg/m2 per day IV on Days 1-5 with SCH 717454 on Day 1. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 4 |
Estimated Completion Date | December 2010 |
Estimated Primary Completion Date | December 2010 |
Eligibility Criteria | Inclusion Criteria: - Each subject must be <= 21 years of age (older subjects may be allowed on study on a case-by-case basis). A subject may be of either sex, and of any race/ethnicity. - Each subject must have histologic confirmation of the advanced solid tumor, except for brainstem tumors. - Each subject must have Karnofsky performance score of >= 50 (if subject is > 16 years of age) or a Lansky score of > 50 (if subject is <= 16 years of age). - Each subject must have adequate organ function during Screening. - Each subject must be able to adhere to dose and visit schedules. Exclusion Criteria: - A subject must not have a history of another malignancy. - A subject must not have uncontrolled diabetes mellitus. - A subject must not have persistent, unresolved common terminology criteria for adverse events (CTCAE) Grade >=2 drug-related toxicity associated with previous treatment. - A subject must not have known hypersensitivity to other antibodies, or any accompanying excipients associated with these medications. - A female subject must not be breast-feeding, pregnant, intending to become pregnant, or have a positive pregnancy test at Screening. - A subject must not be known to have human immunodeficiency virus (HIV) infection or known HIV-related malignancy. - A subject must not be known to have active Hepatitis B, or Hepatitis C. - A subject must not have any serious or uncontrolled infection. |
Gender | Both |
Ages | N/A |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00960063 |
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Other Study ID Numbers | P05883 |
Has Data Monitoring Committee | No |
Information Provided By | Merck Sharp & Dohme Corp. |
Study Sponsor | Merck Sharp & Dohme Corp. |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | January 2014 |