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

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343564
• Other study ID #: CY 2121
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2006
• Est. completion date: July 2010

Study information

• Verified date: January 2020
• Source: Cytokinetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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.
• SB-743921
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Locations

Country	Name	City	State
Russian Federation	Russian Medical Academy of Postgraduate Education	Moscow
Russian Federation	St. Petersburg State PAVLOV Medical University	Saint Petersburg
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Sarah Cannon Cancer Research Institute	Nashville	Tennessee
United States	Cornell University Medical Center	New York	New York
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Memorial Sloan-Kettering Caner Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cytokinetics

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.	Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).	28 days
Secondary	Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Secondary	Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15		Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose