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

January 9, 2020 updated by: Cytokinetics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Russian Medical Academy of Postgraduate Education
      • Saint Petersburg, Russian Federation, 197002
        • St. Petersburg State Pavlov Medical University
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center
      • New York, New York, United States, 10021
        • Cornell University Medical Center
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Caner Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Dose Escalation
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.
Drug: SB-743921
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.
Experimental: Phase 2 Fixed Dose
Phase 2 fixed dose based on Phase I findings stratified by NHL type
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.
Drug: SB-743921
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.
Time Frame: 28 days
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 Outcome Measures

Outcome Measure
Time Frame
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose
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
Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytokinetics

Investigators

  • Principal Investigator: Owen O'Connor, M.D./Ph.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 21, 2006

First Submitted That Met QC Criteria

June 21, 2006

First Posted (Estimate)

June 23, 2006

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CY 2121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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