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| Sponsor: | Cytokinetics |
|---|---|
| Information provided by: | Cytokinetics |
| ClinicalTrials.gov Identifier: | NCT00343564 |
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 I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2006 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
|
|
2: Experimental
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| Contact: John Lewandowski, BS | (609) 799-7580 ext 398 | jlewandowski@theradex.com |
| United States, New Jersey | |
| Hackensack University Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Peggy Ford 201-336-8612 pford@humed.com | |
| Principal Investigator: Andre Goy, MD | |
| United States, New York | |
| Cornell University Medical Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Trish Glynn, BS 212-746-6738 pwg2002@med.cornell.edu | |
| Principal Investigator: John P Leonard, MD | |
| Herbert Irving Comprehensive Cancer Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Ameet Narwal 212-342-3590 an2284@columbia.edu | |
| Principal Investigator: Owen O'Connor, MD | |
| Memorial Sloan-Kettering Caner Center | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Payal Dixit 646-227-2190 dixitp@mskcc.org | |
| Principal Investigator: John Gerecitano, MD | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Reynaldo Garcia 919-966-4432 reynaldo_garcia@med.unc.edu | |
| Principal Investigator: Hendrik Van Deventer, MD | |
| United States, Tennessee | |
| Sarah Cannon Cancer Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: Sharon Calvert, BSN 615-329-7235 sharon.calvert@scresearch.net | |
| Principal Investigator: John D Hainsworth, MD | |
| Russian Federation | |
| Russian Medical Academy of Postgraduate Education | Recruiting |
| Moscow, Russian Federation, 115478 | |
| Contact: Gayane Tumyan, Dr +7(095)324-98-29 gaytum@mail.ru | |
| Principal Investigator: Gayane Tumyan, Dr | |
| St. Petersburg State PAVLOV Medical University | Recruiting |
| Saint Petersburg, Russian Federation, 197002 | |
| Contact: Boris Afanasyev, MD +7(812)233-8307 bmt-lymphoma@spmu.ru | |
| Principal Investigator: Boris Afanasyev, MD | |
| Principal Investigator: | Owen O'Connor, M.D./Ph.D. | Columbia University |
More Information
| Responsible Party: | Cytokinetics, Inc. ( Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer ) |
| Study ID Numbers: | CY 2121 |
| Study First Received: | June 21, 2006 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00343564 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Russia: Pharmacological Committee, Ministry of Health |
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Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Non-Hodgkin Lymphoma Lymphoproliferative Disorders Hodgkin Disease |