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SB-743921

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Cytokinetics, Incorporated|Last Updated: Jan 13, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

SB-743921 · 1 trial · 2 indications

Phase 1 1
NCT00343564A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin LymphomaNon-Hodgkin's Lymphoma
COMPLETED68 Analytics
PHASE1COMPLETED
A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.
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 Endpoints

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
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
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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Dose EscalationEXPERIMENTALPhase 1 dose escalation without and with GCSF support
Phase 2 Fixed DoseEXPERIMENTALPhase 2 fixed dose based on Phase I findings stratified by NHL type

Interventions

NameTypeDescription
SB-743921DRUGPhase 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 li...

Countries:United StatesRussia
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Frequently asked questions about SB-743921

What is SB-743921 used for?

SB-743921 is an investigational small molecule being studied for the treatment of Non-Hodgkin's Lymphoma. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated in patients with Non-Hodgkin's Lymphoma and Hodgkin's Disease.

Who makes SB-743921?

SB-743921 is being developed by Cytokinetics, Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CYTK. The company is conducting clinical research on this investigational oncology drug.

What phase is SB-743921 in?

SB-743921 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for Non-Hodgkin's Lymphoma.

What clinical trials is SB-743921 in?

SB-743921 has one completed Phase 1 clinical trial, identified as NCT00343564. This study evaluated SB-743921 in patients with Non-Hodgkin's Lymphoma and Hodgkin's Disease, enrolling 68 participants across the United States and Russia.

Is SB-743921 the same as any other drug?

SB-743921 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this compound in the available clinical trial information.