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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00779584 |
This first study in humans of SCH 900776 will evaluate its safety and tolerability when given as monotherapy or in combination with gemcitabine to patients with advanced solid tumors or lymphoma. Subjects will be enrolled in cohorts that will receive sequentially higher doses of SCH 900776 in combination with standard doses of gemcitabine 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 |
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Hodgkin Disease Lymphoma, Non-Hodgkin Neoplasms |
Drug: SCH 900776 Drug: Gemcitabine |
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 as Monotherapy and in Combination With Gemcitabine in Subjects With Advanced Solid Tumors or Lymphoma |
Estimated Enrollment: | 60 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: SCH 900776
SCH 900776 will be administered to sequential dose cohorts as a 15-minute infusion starting with 10 mg/m2. Doses of SCH 900776 for will either be doubled or increased by 40%, depending on the part of the dose escalation (dose of gemcitabine) and toxicities observed. SCH 900776 will be given as monotherapy on Cycle 0 Day 1 for subjects in the dose escalation portion, and starting with Cycle 1 in combination with gemcitabine on Days 1 and 8 of a 21 day treatment cycle for all subjects.
Drug: Gemcitabine
Depending on the part of the dose escalation portion of the trial, the subject will receive 800 mg/m2, 1000 mg/m2 or based upon safety, 1250 mg/m2. Starting with Cycle 1, gemcitabine will be administered intravenously over 30 minutes on Days 1 and 8 of a 21-day treatment cycle.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
United States, Arizona | |
Investigational Site 1 | Recruiting |
Scottsdale, Arizona, United States, 85260 | |
United States, Florida | |
Investigational Site 3 | Recruiting |
Tampa, Florida, United States, 33612 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05248 |
Study First Received: | October 22, 2008 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00779584 |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult Gemcitabine |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Hodgkin Disease Lymphoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Radiation-Sensitizing Agents Therapeutic Uses |