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CompletedNCT00741871Updated Apr 20, 2012

A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

A Phase 1 interventional study of SB1518 in Lymphoma, Malignant, Hodgkin's Lymphoma and B Cell Lymphoma, sponsored by S*BIO. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-20.

Sponsored by S*BIO · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given alone once daily by mouth to subjects with advanced lymphoid malignancies.

02

Conditions studied

  • Lymphoma, Malignant
  • Hodgkin's Lymphoma
  • B Cell Lymphoma

Keywords

  • Lymphoid malignancies
  • Hodgkin's Lymphoma
  • Diffuse large B cell lymphoma
03

In context

Lymphoma

5,623 studies on the registry are indexed under Lymphoma; 823 are open to participants now.

This study's enrollment of 35 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

S*BIO is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects with histologically documented diagnosis of a lymphoid malignancy as defined in the World Health Organization (WHO) classification scheme except for those listed in Exclusion Criteria
  • Subject must have received at least 2 prior regimens for their lymphoid malignancy, one of which was an anthracycline-containing combination regimen and have shown disease relapse or did not respond to the prior regimen
  • Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant
  • Subjects must have measurable lesions (at least one target lesion measuring 2cm in diameter) by computerized tomography (CT) scan
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • All men of reproductive potential and women of child-bearing potential must agree to practice effective contraception during the entire study period and for one month after the last study treatment unless documentation of infertility exists. Additionally, women of child-bearing potential must have a negative pregnancy test within 14 days prior to the first dose of study drug
  • Able to understand and willing to sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma
  • History of or active Central Nervous System (CNS) malignancy
  • Have undergone allogeneic stem cell transplant and were treated with immunosuppressing agent within the past 6 months
  • Active Graft-versus-host disease (GVHD)
  • Uncontrolled inter-current illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Subjects receiving antibiotics for infections that are under control may be included in the study
  • Concurrent malignancy, except those subjects with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for the study
  • Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy)
  • Known active Hepatitis A, B or C
  • Women who are pregnant or lactating
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Interventions

  • DrugSB1518

    SB1518 taken orally daily for 28 consecutive days in a 28 day cycle

06

What researchers measure

Primary outcomes

  1. To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.

    Time frame: Throughout the study

Secondary outcomes

  1. To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies.

    Time frame: Throughout the study

  2. To assess the pharmacokinetic and pharmacodynamic profile of SB1518.

    Time frame: Throughout the study

07

Study locations

1 site
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Younes A, Romaguera J, Fanale M, McLaughlin P, Hagemeister F, Copeland A, Neelapu S, Kwak L, Shah J, de Castro Faria S, Hart S, Wood J, Jayaraman R, Ethirajulu K, Zhu J. Phase I study of a novel oral Janus kinase 2 inhibitor, SB1518, in patients with relapsed lymphoma: evidence of clinical and biologic activity in multiple lymphoma subtypes. J Clin Oncol. 2012 Nov 20;30(33):4161-7. doi: 10.1200/JCO.2012.42.5223. Epub 2012 Sep 10. PubMed 22965964 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2008, a primary completion of Oct 2011 and a completion of Oct 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2008
First posted
Aug 26, 2008
Start
Jul 2008
Primary completionActual
Oct 2011
CompletionActual
Oct 2011
Last update
Apr 20, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00741871
Lead sponsor
S*BIO
Responsible party
Sponsor
First posted
Aug 26, 2008
Start date
Jul 2008
Primary completion
Oct 2011
Completion
Oct 2011
Last update
Apr 20, 2012

Study contacts

Anas Younes, M.D.
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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