Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL or MM
This study has been completed.
Sponsor:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648739
First received: March 28, 2008
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine the safety and best dose of ALXN6000 in treating relapsing or refractory B-CLL or MM and to study how ALXN6000 may help the immune system fight cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
B-cell Chronic Lymphocytic Leukemia Multiple Myeloma |
Drug: ALXN6000 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Open Label Study To Evaluate The Safety, Pharmacokinetics And Pharmacodynamics Of ALXN6000 In Patients With Relapsing Or Refractory B-Cell Chronic Lymphocytic Leukemia Or Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Alexion Pharmaceuticals:
Primary Outcome Measures:
- Obtain dose, safety, PK, and PD information about ALXN6000. [ Time Frame: From first dose through 10 weeks after the last dose ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Obtain biological information on ALXN6000 including binding to CD200 on B CLL cells; describe the effect of ALXN6000 in B-CLL patients on ORR and its components of CR, PR, nPR and SD; and in MM patients on response as defined in the protocol [ Time Frame: From first dose through 10 weeks after the last dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 26 |
| Study Start Date: | June 2008 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1, 2, 3, 4, 5, 6, and 7
ALXN6000 dose ranging cohorts numbered 1-7 with dosages of 50 mg/m2 to 600 mg/m2.
|
Drug: ALXN6000
Part A is a comparison of different dosages of ALXN6000 by cohort ranging from 50 mg/m2 up to 600 mg/m2 given as a single IV dose. Once the most appropriate dose is determined it will be given over a 28 day cycle for 4 cycles in Part B Cohort 1 = 50 mg/m2 Cohort 2 = 100 mg/m2 Cohort 3 = 200 mg/m2 Cohort 4 = 300 mg/m2 Cohort 5 = 400 mg/m2 Cohort 6 = 500 mg/m2
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Relapsing or Refractory B CLL or MM
- ECOG performance status 0-2
- Anticipated survival of greater than 6 months.
- Female patients of childbearing potential must agree to use two forms of contraception
- Patients must have a standard indication for treatment of their malignancy
- Is willing and able to give written informed consent.
Exclusion Criteria:
- Absolute neutrophil count (ANC) < 1000 x 109/L
- Platelet count < 50,000 x 109/L
- Pregnant or lactating women.
- Prior history of autoimmune hemolysis requiring therapy.
- Prior history of immune thrombocytopenia.
- Active autoimmune disease requiring immunosuppressive therapy.
- Positive Coombs' Test (neither Direct or Indirect)
- Ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
- Prior stem cell transplantation within 4 weeks prior to enrollment.
- Prior chemotherapy for the applicable malignancy within 30 days of enrollment.
- Neurosurgery or cranial radiation therapy within one year of enrollment.
- Clinically significant renal, hepatic or heart disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648739
Locations
| United States, Arizona | |
| Arizona Cancer Center at UMC North | |
| Tucson, Arizona, United States, 85719 | |
| United States, Georgia | |
| Emory Winship Cancer Institute | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New Jersey | |
| Hematology Oncology Assoc. of Northern NJ Carol G. Simon Cancer Center | |
| Morristown, New Jersey, United States, 07962 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Alexion Pharmaceuticals
Investigators
| Principal Investigator: | Leonard Heffner | Emory University |
| Principal Investigator: | Duruka Mahadevan | University of Arizona College of Medicine |
| Principal Investigator: | Charles Farber | HOANNJ-Carol G. Simon Cancer Center |
| Principal Investigator: | Moshe Talpaz | University of Michigan Cancer Center |
| Principal Investigator: | Mark Lanasa | Duke University |
More Information
No publications provided
| Responsible Party: | Alexion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00648739 History of Changes |
| Other Study ID Numbers: | C07-003 |
| Study First Received: | March 28, 2008 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alexion Pharmaceuticals:
|
B-cell Chronic Lymphocytic Leukemia Leukemia Multiple Myeloma CD200 Anti-CD200 |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on June 13, 2013