Phase 2
N=68
A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma
Non-Hodgkin's Lymphoma · Hodgkin's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00343564 ↗Enrolled (actual)
68
Serious AEs
19.1%
Results posted
Oct 2016
Primary outcome: Primary: Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. — 2; 3; 4; 5 mg/m2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SB-743921 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cytokinetics
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. |
2; 3; 4; 5; 6; 6 | — |
| SECONDARY Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 |
172; 348; 357; 514; 600; 689 | — |
| SECONDARY Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1 |
1.20; 1.00; 1.00; 1.00; 1.08; 1.00 | — |
| SECONDARY Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 |
36.9; 61.6; 59.5; 79.1; 133; 103 | — |
| SECONDARY Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1 |
1807; 2800; 3269; 3707; 5838; 5359 | — |
| SECONDARY Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 |
220; 323; 365; 599; 717; 835 | — |
| SECONDARY Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 |
1.00; 1.00; 1.00; 1.00; 1.00; 1.00 | — |
| SECONDARY Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 |
29.2; 84.2; 58.5; 84.6; 138; 92.4 | — |
| SECONDARY Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15 |
1809; 2363; 3380; 4105; 5869; 5116 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00343564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.