A Study of SB-743921 in Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Cytokinetics
ClinicalTrials.gov Identifier:
NCT00343564
First received: June 21, 2006
Last updated: January 24, 2011
Last verified: January 2011
  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

Resource links provided by NLM:


Further study details as provided by Cytokinetics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343564

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
Sponsors and Collaborators
Cytokinetics
Investigators
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 July 31, 2014