B Cell Lymphoma, Hodgkin's Lymphoma, Lymphoma, Malignant
Conditions
Keywords
Lymphoid malignancies, Hodgkin's Lymphoma, Diffuse large B cell lymphoma
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.
Interventions
DRUGSB1518
SB1518 taken orally daily for 28 consecutive days in a 28 day cycle
Sponsors
S*BIO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies. | Throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies. | Throughout the study |
| To assess the pharmacokinetic and pharmacodynamic profile of SB1518. | Throughout the study |
Countries
United States
Outcome results
None listed