Clinical trial NCT00741871: A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Official title: A Phase 1 Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphoma, Malignant
Hodgkin's Lymphoma
B Cell Lymphoma
Keywords: Lymphoid malignancies
Hodgkin's Lymphoma
Diffuse large B cell lymphoma
Lead sponsor: S*BIO
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.
timeFrame: Throughout the study
Secondary outcomes:
measure: To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies.
timeFrame: Throughout the study
measure: To assess the pharmacokinetic and pharmacodynamic profile of SB1518.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Anas Younes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.