A Study of SB-743921 in Non-Hodgkin's Lymphoma
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Purpose
Cytokinetics' CY 2121 Study is an early-phase trial arranged into two phases. The objectives of the first phase of the study are to assess the safety, tolerability and to identify the maximum tolerated dose of the drug SB-743921 in patients with Hodgkin's Disease and Non-Hodgkin's Lymphomas. The second phase of the study is designed to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma Hodgkin's Disease |
Drug: SB-743921 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I-II Study to Determine the Safety, Pharmacokinetics and Potential Efficacy of Intravenous Administration of SB-743921 on Days 1 and 15 of a 28-Day Dosing Schedule in Patients With Non-Hodgkin Lymphoma and Hodgkin Lymphoma |
- Phase 1: Determination of Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) first without and then with administration of prophylactic G-CSF. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Phase 2: Frequency of Disease Response according to IWRC Criteria (Cheson,1999) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Phase 1: Pharmacokinetics of SB-743921 administered on a Days 1 and 15 of a 28 Day Cycle. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Phase 2: Overall survival, progression-free survival. Time to and duration of response in patients who respond (CR, CRu, PR) to treatment. Frequency of disease response by (18-FDG PET), effects of SB-743921 on biomarkers [ Time Frame: >=28 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Phase 1 dose escalation without and with GCSF support
|
Drug: SB-743921
Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops.
|
|
Experimental: 2
Phase 2 fixed dose based on Phase I findings stratified by NHL type
|
Drug: SB-743921
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Phase 1: Patients with evaluable or measurable (by MRI or CT) Hodgkin's Disease or Non-Hodgkin's Lymphoma. Phase 2: Patients with Measurable Non-Hodgkin's Lymphomas (Indolent or Aggressive) only. - Patients with Indolent NHL must be relapsed or refractory to at least one prior line of therapy (CHOP, CVP, chlorambucil or fludaribine). Prior treatment with Rituximab is required. - Patients with Aggressive NHL refractory to (or relapsed from) at least one CHOP-based therapy who have had prior treatment with Rituximab and who are not candidates for high-dose chemotherapy or autologous stem cell transplantation. - ECOG performance status 0-2 - Autologous stem cell transplant recipients are eligible if 100 days have elapsed since procedure. Exclusion Criteria: Phase 1: History of prior radioimmunotherapy (Bexxar, Zevalin); These patients ARE permitted in the Phase 2 trial. - Current active malignancy besides NHL, except excised non-melanoma skin cancer, in-situ cervical or bladder cancer or early stage prostate cancer. - Patients with leptomeningeal of CNS lymphoma - Known allergy to and/or receipt of treatments contraindicated by administration of G-CSF - Patients with active Hepatitis B or C, or patients with HIV infection. - Pregnant or breast-feeding females. - Previous treatment with a KSP inhibitor
Contacts and Locations| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Cornell University Medical Center | |
| New York, New York, United States, 10021 | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Caner Center | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Tennessee | |
| Sarah Cannon Cancer Research Institute | |
| Nashville, Tennessee, United States, 37203 | |
| Russian Federation | |
| Russian Medical Academy of Postgraduate Education | |
| Moscow, Russian Federation, 115478 | |
| St. Petersburg State PAVLOV Medical University | |
| Saint Petersburg, Russian Federation, 197002 | |
| Principal Investigator: | Owen O'Connor, M.D./Ph.D. | Columbia University |
More Information
No publications provided
| Responsible Party: | Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer, Cytokinetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00343564 History of Changes |
| Other Study ID Numbers: | CY 2121 |
| Study First Received: | June 21, 2006 |
| Last Updated: | January 24, 2011 |
| Health Authority: | United States: Food and Drug Administration Russia: Pharmacological Committee, Ministry of Health |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013