Non-Hodgkin's LymphomaPhase 1/2NCT00343564

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

A Phase 1/2 study testing SB-743921 in people with Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Cytokinetics at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Hodgkin's Lymphoma, Hodgkin's Disease
What is being tested?: SB-743921
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 8 sitesin 2 countries
Study dates: Apr 2006to Jul 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

United States6 sites

University of North Carolina
Chapel Hill, North Carolina, 27599
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Sarah Cannon Cancer Research Institute
Nashville, Tennessee, 37203
Cornell University Medical Center
New York, New York, 10021
Memorial Sloan-Kettering Caner Center
New York, New York, 10021
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032

Other trials in United States

Russia2 sites

Russian Medical Academy of Postgraduate Education
Moscow, 115478
St. Petersburg State PAVLOV Medical University
Saint Petersburg, 197002

Other trials in Russia

About this study

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

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.

Conditions: Non-Hodgkin's Lymphoma, Hodgkin's Disease
Being tested: SB-743921
Medical subject headings: Lymphoma, Non-Hodgkin, Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SB-743921Drug
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.
SB-743921Drug
Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Study groups in NCT00343564
Study group	Role	What they receive
Phase 1 Dose Escalation	Experimental	Phase 1 dose escalation without and with GCSF support Receives: Drug: SB-743921
Phase 2 Fixed Dose	Experimental	Phase 2 fixed dose based on Phase I findings stratified by NHL type Receives: Drug: SB-743921

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 28 days

Secondary outcomes (8)

Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Jul 2010

First posted23 Jun 2006 (estimated)
Study startApr 2006
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00343564
Sponsor's protocol ID: CY 2121
Status last verified: Jan 2020
First submitted: 21 Jun 2006
Last updated: 13 Jan 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25665464

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-Hodgkin's Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00343564
Acronym / sponsor ID: CY 2121
Conditions: Non-Hodgkin's Lymphoma, Hodgkin's Disease
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: CytokineticsIndustry (pharma, biotech, devices)
Study start: Apr 2006
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 23 Jun 2006 (estimated)
Results: Posted 4 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phase 1 Dose Escalation	Experimental	Drug: SB-743921Phase 1 dose escalation without and with GCSF support
Phase 2 Fixed Dose	Experimental	Drug: SB-743921Phase 2 fixed dose based on Phase I findings stratified by NHL type

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SB-743921Phase 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	Phase 1 Dose Escalation
SB-743921Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.	Drug	Phase 2 Fixed Dose

Primary outcome

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).

8 secondary outcomes

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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 4 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 mg/m2 Without GCSF	6	6
3 mg/m2 Without GCSF	7	7
4 mg/m2 Without GCSF	3	3
5 mg/m2 Without GCSF	7	7
6 mg/m2 Without GCSF	10	10
7 mg/m2 Without GCSF	9	9
6 mg/m2 With GCSF	4	4
7 mg/m2 With GCSF	3	3
8 mg/m2 With GCSF	3	3
9 mg/m2 With GCSF	8	8
10 mg/m2 With GCSF	8	8

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

Time frame: 28 days. Number. Unit: mg/m2

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n = 4	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n = 6	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n = 3	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n = 5	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n = 6	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n = 9	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n = 4	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n = 3	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n = 3	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) n = 7	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) n = 6
Value	2	3	4	5	6	6	6	7	8	9	9

Population analysed: Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations. Efficacy evaluable; any patient who received both cycles of treatment.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 mg/m2 Without GCSF	2 of 5 (40%)	5 of 5 (100%)	Not reported
3 mg/m2 Without GCSF	0 of 6 (0%)	6 of 6 (100%)	Not reported
4 mg/m2 Without GCSF	0 of 3 (0%)	3 of 3 (100%)	Not reported
5 mg/m2 Without GCSF	0 of 6 (0%)	6 of 6 (100%)	Not reported
6 mg/m2 Without GCSF	3 of 10 (30%)	10 of 10 (100%)	Not reported
7 mg/m2 Without GCSF	1 of 9 (11.1%)	8 of 9 (88.9%)	Not reported
6 mg/m2 With GCSF	1 of 4 (25%)	4 of 4 (100%)	Not reported
7 mg/m2 With GCSF	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
8 mg/m2 With GCSF	0 of 3 (0%)	3 of 3 (100%)	Not reported
9 mg/m2 With GCSF	1 of 7 (14.3%)	7 of 7 (100%)	Not reported
10 mg/m2 With GCSF	3 of 7 (42.9%)	7 of 7 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25665464O'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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Owen O'Connor, M.D./Ph.D. principal investigator

Columbia University

8 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SB-743921 in people with Non-Hodgkin's Lymphoma and Hodgkin's Disease, run by Cytokinetics at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF. (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00343564, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.