A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma

NCT ID: NCT00343564

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-07-31

Brief Summary

This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the study was not initiated.

Conditions

Non-Hodgkin's Lymphoma; Hodgkin's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1 Dose Escalation

Phase 1 dose escalation without and with GCSF support

Group Type: EXPERIMENTAL

SB-743921

Intervention Type: DRUG

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.

Phase 2 Fixed Dose

Phase 2 fixed dose based on Phase I findings stratified by NHL type

Group Type: EXPERIMENTAL

SB-743921

Intervention Type: DRUG

Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Interventions

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.

Intervention Type: DRUG

SB-743921

Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytokinetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Owen O'Connor, M.D./Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Hackensack University Medical Center

Hackensack, New Jersey, United States

Cornell University Medical Center

New York, New York, United States

Memorial Sloan-Kettering Caner Center

New York, New York, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Sarah Cannon Cancer Research Institute

Nashville, Tennessee, United States

Russian Medical Academy of Postgraduate Education

Moscow, , Russia

St. Petersburg State PAVLOV Medical University

Saint Petersburg, , Russia

Countries

United States; Russia

References

O'Connor OA, Gerecitano J, Van Deventer H, Hainsworth J, Zullo KM, Saikali K, Seroogy J, Wolff A, Escandon R. The addition of granulocyte-colony stimulating factor shifts the dose limiting toxicity and markedly increases the maximum tolerated dose and activity of the kinesin spindle protein inhibitor SB-743921 in patients with relapsed or refractory lymphoma: results of an international, multicenter phase I/II study. Leuk Lymphoma. 2015;56(9):2585-91. doi: 10.3109/10428194.2015.1004167. Epub 2015 Sep 11.

Reference Type: DERIVED

PMID: 25665464 (View on PubMed)

Other Identifiers

CY 2121

Identifier Type: -

Identifier Source: org_study_id