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| Sponsor: | AVEO Pharmaceuticals, Inc. |
|---|---|
| Information provided by (Responsible Party): | AVEO Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00725634 |
Purpose
Phase 1 study to determine safety, tolerability, dose-limiting toxicities (DLTs), and recommended Phase 2 dose of AV-299 administered IV as monotherapy to patients with relapsed or refractory solid tumors, lymphoma, or multiple myeloma. The study will also determine the safety, tolerability and DLTs of AV-299 in combination with erlotinib in patients with relapsed or refractory solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Lymphomas Multiple Myeloma |
Biological: AV-299 Biological: AV-299 + erlotinib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of AV-299 (Formerly SCH 900105) Administered by IV Infusion as Monotherapy in Advanced Solid Tumors, Lymphomas, or Multiple Myeloma or in Combination With Erlotinib in Advanced Solid Tumors |
| Enrollment: | 41 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AV-299 Dose Escalation Arm
AV-299 Administered by IV Infusion as Monotherapy in Advanced Solid Tumors, Lymphomas, or Multiple Myeloma
|
Biological: AV-299
AV-299 monotherapy will be given as intravenous infusion in dose-escalation cohorts at 2, 5, 10, and 20 mg/kg. Once the RP2D has been determined the cohort may be expanded to include up to 12 patients for safety assessment and enriched with up to 12 additional Multiple Myeloma patients.
Other Name: Formerly SCH 900105
|
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Experimental: AV-299 in combination with erlotinib
AV-299 Administered by IV Infusion in Combination with Erlotinib (150 mg daily) in Advanced Solid Tumors
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Biological: AV-299 + erlotinib
AV-299 will be given as intravenous infusion at RP2D in combination with erlotinib (150 mg daily). Once the combination-RP2D has been determined the cohort may be expanded to include up to 12 additional patients.
Other Name: Formerly SCH 900105
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For subjects in the dose-escalation cohorts and the Phase 1b evaluation of AV-299 (formerly SCH 900105) in combination with erlotinib:
-- Serum AST/ALT levels ≤3 × ULN for the reference laboratory
For subjects in the RP2D safety expansion cohort:
Diagnosis and Main Criteria for Inclusion for the Multiple Myeloma Exploratory Cohort Subjects to be Included
Measurable disease assessed by one of the following:
Exclusion Criteria:
Myocardial infarction (MI), severe /unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder.
Additional Exclusion Criteria for Subjects Enrolled in the Phase 1b Evaluation of AV-299 (formerly SCH 900105) in Combination with Erlotinib:
Exclusion for the Multiple Myeloma Exploratory Cohort
Myocardial infarction (MI), severe /unstable angina pectoris, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or seizure disorder.
NOTE: Maintenance steroid therapies of ≤ 20 mg/day prednisone, ≤ 4 mg/day dexamethasone, ≤ 80 mg/day hydrocortisone, or equivalent are allowed provided that the subject is on a stable dose for at least 2 weeks prior to first dose of study drug or the dose has not been adjusted upwards in the 2 weeks prior to first dose of study drug.
Contacts and Locations| United States, Arizona | |
| Investigational Site 2 | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, Ohio | |
| Investigational Site 5 | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| Investigational Site 1 | |
| San Antonio, Texas, United States, 78229 | |
| Study Director: | Jaroslaw Jac, MD | AVEO Pharmaceuticals, Inc. |
More Information
| Responsible Party: | AVEO Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00725634 History of Changes |
| Other Study ID Numbers: | P05538 |
| Study First Received: | July 28, 2008 |
| Last Updated: | August 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Neoplasms, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Neoplasms by Histologic Type, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors, Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
|
Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Erlotinib Protein Kinase Inhibitors Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |