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NCT Number: NCT00343564

A Study of SB-743921 in 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.

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Key information

Conditions

Non-Hodgkin's Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin's Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Russian Medical Academy of Postgraduate Education, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SB-743921

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Cytokinetics

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2006
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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