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A Study of SCH 717454 in Combination With Different Treatment Regimens in Pediatric Subjects With Advanced Solid Tumors (Study P05883)

2014-07-23 21:13:37 | BioPortfolio

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).

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Neoplasms

Intervention

Temozolomide, Irinotecan, and SCH 717454, Vincristine, Doxorubicin, Cyclophosphamide (CAV), and SCH 717454, Ifosfamide, Etoposide (IE), and SCH 717454

Status

Active, not recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:37-0400

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Medical and Biotech [MESH] Definitions

A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE.

Positional isomer of CYCLOPHOSPHAMIDE which is active as an alkylating agent and an immunosuppressive agent.

A major cytochrome P-450 enzyme which is inducible by PHENOBARBITAL in both the LIVER and SMALL INTESTINE. It is active in the metabolism of compounds like pentoxyresorufin, TESTOSTERONE, and ANDROSTENEDIONE. This enzyme, encoded by CYP2B1 gene, also mediates the activation of CYCLOPHOSPHAMIDE and IFOSFAMIDE to MUTAGENS.

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the LIVER to form the active aldophosphamide. It has been used in the treatment of LYMPHOMA and LEUKEMIA. Its side effect, ALOPECIA, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN.

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