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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00907517 |
Purpose
This study of SCH 900776 will evaluate its safety and tolerability when given in combination with cytarabine to patients with acute leukemias. Subjects in the Dose-Escalation Part will be enrolled in cohorts that will receive sequentially higher doses of SCH 900776 in combination with standard doses of cytarabine. Only one combination treatment cycle of approximately 4 to 6 weeks is anticipated, but subjects may receive additional cycles if clinically indicated after discussion between the investigator and the sponsor. The recommended combination doses for a Phase 2 trial (RP2D) will be determined based on safety and biological activity. Up to 10 to 15 additional subjects will be studied at the combination-RP2D.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelogenous Leukemia, Acute Leukemia, Lymphocytic, Acute Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Myelogenous Leukemia, Chronic, Aggressive Phase |
Drug: SCH 900776 Drug: Cytarabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Dose-Escalation Study of SCH 900776 in Combination With Cytarabine in Subjects With Acute Leukemias |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Single arm (various dose cohorts): Experimental |
Drug: SCH 900776
SCH 900776 will be administered to sequential dose cohorts as a 15 minute infusion on Days 2 and 3 and again on Days 11 and 12 in combination with cytarabine. The SCH 900776 starting dose in the Dose-Escalation Part will be 10 mg/m2, and the dose will be doubled with each sequential cohort until 40 mg/m2 is reached, at which point all subsequent dose escalations will occur in 40% increments. If one DLT occurs in Cycle 1 of any dose level, dose escalation will change from dose doubling to 40% increments for the subsequent dose levels.
Drug: Cytarabine
Cytarabine will be administered as continuous intravenous infusion (CIV) at a total dose of 2.0 g/m² over 72 hours (667 mg/m2/24 h) on Days 1-3 and 10-12
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have a histologically or cytologically confirmed diagnosis of relapsed and/or refractory acute leukemia, including
Exclusion Criteria:
Contacts and Locations| Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
| United States, Maryland | |
| Investigational Site 1 | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Johns Hopkins Clinical Research Office 410-955-8866 jhcccro@jhmi.edu | |
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P05247 |
| Study First Received: | May 21, 2009 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00907517 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Leukemia, Myeloid, Acute Leukemia Therapeutic Uses Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Leukemia, Myeloid, Accelerated Phase Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases |