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| Sponsor: | Xencor, Inc. |
|---|---|
| Information provided by: | Xencor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00606645 |
Purpose
An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 will be conducted to define the MTD or recommended dose(s) for further study, to determine safety and tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior therapeutic regimens. There will be no intra-patient dose escalation.
| Condition | Intervention | Phase |
|---|---|---|
|
Hodgkin Lymphoma Anaplastic Large Cell Lymphoma |
Biological: XmAb2513 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Study of Every Other Week XmAb®2513 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma |
| Estimated Enrollment: | 48 |
| Study Start Date: | December 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: XmAb2513
XmAb2513 is An anti-CD30 antibody that will be given at doses of 0.3, 1.0, 3.0, 6.0, 9.0 or 12.0 mg/kg
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Required baseline laboratory data:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Anas Younes, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Rolondo Enoch, Xencor |
| ClinicalTrials.gov Identifier: | NCT00606645 History of Changes |
| Other Study ID Numbers: | XmAb2513-01 |
| Study First Received: | January 21, 2008 |
| Last Updated: | February 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Anaplastic Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, T-Cell |