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

Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741871
• Other study ID #: SB1518-2007-002
• Status: Completed
• Phase: Phase 1
• First received: August 22, 2008
• Last updated: April 19, 2012
• Start date: July 2008
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: S*BIO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
S*BIO

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies.		Throughout the study	Yes
Secondary	To assess the pharmacokinetic and pharmacodynamic profile of SB1518.		Throughout the study	No