search
Back to results

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

Primary Purpose

Non-Hodgkin's Lymphoma, Hodgkin's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SB-743921
SB-743921
Sponsored by
Cytokinetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hackensack University Medical Center
  • Cornell University Medical Center
  • Memorial Sloan-Kettering Caner Center
  • Herbert Irving Comprehensive Cancer Center
  • University of North Carolina
  • Sarah Cannon Cancer Research Institute
  • Russian Medical Academy of Postgraduate Education
  • St. Petersburg State PAVLOV Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase 1 Dose Escalation

Phase 2 Fixed Dose

Arm Description

Phase 1 dose escalation without and with GCSF support

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1
Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15

Full Information

First Posted
June 21, 2006
Last Updated
January 9, 2020
Sponsor
Cytokinetics
search

1. Study Identification

Unique Protocol Identification Number
NCT00343564
Brief Title
A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Hodgkin's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1 Dose Escalation
Arm Type
Experimental
Arm Description
Phase 1 dose escalation without and with GCSF support
Arm Title
Phase 2 Fixed Dose
Arm Type
Experimental
Arm Description
Phase 2 fixed dose based on Phase I findings stratified by NHL type
Intervention Type
Drug
Intervention Name(s)
SB-743921
Intervention Description
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
Intervention Name(s)
SB-743921
Intervention Description
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
Primary Outcome Measure Information:
Title
Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.
Description
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).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
Title
Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15
Time Frame
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Owen O'Connor, M.D./Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cornell University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan-Kettering Caner Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Sarah Cannon Cancer Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Russian Medical Academy of Postgraduate Education
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
St. Petersburg State PAVLOV Medical University
City
Saint Petersburg
ZIP/Postal Code
197002
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
25665464
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs