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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
AVEO Pharmaceuticals, Inc. |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00725634 |
Purpose
The primary objective of this study is to determine safety, tolerability, dose-limiting toxicities and recommended dose of SCH 900105 administered intravenously (IV) to subjects with relapsed or refractory solid tumors, lymphoma or multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Lymphoma Multiple Myeloma |
Drug: SCH 900105 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase 1 Study of SCH 900105 Administered by IV Infusion in Advanced Solid Tumors, Lymphomas or Multiple Myeloma |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Single arm: Experimental
Subjects will be enrolled sequentially and treated with SCH 900105 in dose-escalating cohorts to determine the RP2D of SCH 900105. The number of cohorts enrolled and the maximum dose administered will depend on observed drug-related dose-limiting toxicity during the first two cycles (Days 1 to 14 of Cycle 1, and/or Days 1 to 14 of Cycle 2). There will be 3 to 6 subjects per cohort, and dose escalation will be performed following the traditional 3+3 rule. Up to 12 additional subjects may be enrolled at the RP2D for an expanded safety assessment (RP2D Safety Expansion Cohort). Up to 12 additional subjects may be enrolled at the RP2D for preliminary assessment of activity in multiple myeloma (Exploratory Cohort for Multiple Myeloma).
|
Drug: SCH 900105
SCH 900105 will be given as an intravenous infusion in dose-escalating cohorts at 2, 5, 10 or 20 mg/kg.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For Advanced Solid Tumors or Lymphoma:
Adequate hematologic, hepatic, renal, and coagulation function with:
For subjects in the RP2D safety expansion cohorts:
For the Multiple Myeloma Exploratory Cohort:
Measurable disease assessed by one of the following:
Adequate hematologic, hepatic, renal, and coagulation function with:
Exclusion Criteria:
For Advanced Solid Tumors or Lymphoma:
For the Multiple Myeloma Exploratory Cohort:
For All Subjects:
Contacts and Locations| Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
| United States, Arizona | |
| Investigational Site 2 | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Ohio | |
| Investigational Site 5 | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Ohio State University Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| United States, Texas | |
| Investigational Site 1 | Recruiting |
| San Antonio, Texas, United States, 78229 | |
More Information
| Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
| Study ID Numbers: | P05538 |
| Study First Received: | July 28, 2008 |
| Last Updated: | January 19, 2010 |
| ClinicalTrials.gov Identifier: | NCT00725634 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |