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| Sponsor: | ImClone LLC |
|---|---|
| Information provided by: | ImClone LLC |
| ClinicalTrials.gov Identifier: | NCT00887926 |
Purpose
The purpose of this study is to determine if IMC-EB10 is safe for patients with leukemia, and also to determine the best dose of IMC-EB10 to give to patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloid Leukemia |
Biological: IMC-EB10 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | An Open-label, Dose Escalation, Phase I Study of IMC-EB10 in Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
IMC-EB10 is 5 mg/kg: Experimental
All patients will receive intravenous infusions of IMC-EB10, with the dose depending on which cohort they are enrolled into.
|
Biological: IMC-EB10
Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5mg/kg. After all patients in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10mg/kg, Cohort 3 - 20mg/kg, Cohort 4 - 30mg/kg. Patients who experience a dose limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Patients may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle
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The purpose of this study is to define the maximum tolerated dose (MTD) and the pharmacokinetic (PK) profile of the anti-FLT3 monoclonal antibody IMC-EB10, administered weekly in patients with AML who have failed to achieve complete remission to a standard induction regimen, relapsed after response to previous antileukemia therapy, or are not eligible for potentially curative or approved salvage options.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has adequate hepatic function, as defined by the following criteria:
The patient has adequate renal function, as defined by the following criteria:
Exclusion Criteria:
The patient has uncontrolled intercurrent illness including, but not limited to the following:
Contacts and Locations| Contact: Shawen F Ilaria, R.N., B.S | 407-343-6113 | shawen.ilaria@imclone.com |
| Contact: Sarah Cappello, MPH | 908-927-8395 | sarah.cappello@imclone.com |
| United States, Ohio | |
| The Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: William Blum, MD 614-293-7526 William.blum@osumc.edu | |
| Contact: Shawna Oxier, RN 614-366-8309 Shawna.Oxier@osumc.edu | |
| Principal Investigator: William Blum, MD | |
| United States, Texas | |
| MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jorge Cortes-Franco, MD 713-792-8393 jcortes@mdanderson.org | |
| Contact: Jody L Hiteshew, R.N 713-792-9192 hiteshew@mdanderson.org | |
| Principal Investigator: Jorge Cortes-Franco, MD | |
| Principal Investigator: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | ImClone LLC ( Chief Medical Officer ) |
| Study ID Numbers: | CP17-0801 |
| Study First Received: | April 23, 2009 |
| Last Updated: | December 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00887926 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AML Leukemia Acute Myeloid Leukemia Antibodies, Monoclonal |
|
Leukemia Neoplasms Neoplasms by Histologic Type Leukemia, Myeloid Leukemia, Myeloid, Acute |