MDACC Study Summary 2008-0105

Study Summary
No. 2008-0105:.......Lymphoma......Anas Younes......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2008-0105

Study Title:	A Phase I Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Physician

New Patient Referral



Name:	Anas Younes	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Lymphoma/Myeloma	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2860 Contact us about clinical trials

General Information



Disease Group:	Lymphoma	Supported By:	S*Bio Pte Ltd

Phase of Study:	Phase I	Return Visit:	Screening visit, Cycle 1, Days 1,8,15, and 22. Cycle 2, Days 1, 8, 15, and 22. Cycle 3, Days 1 and 15. Cycles 4 and up, Day 1. Termination visit, 30 days after last study dose.

Treatment Agents:	SB1518	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerable dose of SB1518 (the drug being studied) that can be given to patients with lymphoid cancer. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary:
· Establish the maximum tolerated dose (MTD) of SB1518 as a single agent when administered orally daily in subjects with advanced lymphoid malignancies.

Secondary:
· Assess the safety and tolerability of SB1518, administered orally once daily in subjects with advanced lymphoid malignancies;
· Assess the pharmacokinetic (PK) profile of SB1518;
· Evaluate pharmacodynamic (PD) activity of SB1518.

Study Status Information



Study Activation / Registration Date:	07/10/2008

IRB Review and Approval Date:	05/06/2008

Study Type:	Phase I

Recruitment Status:	Open

Projected Accrual:	30

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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;

2) 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;

3) Subjects with classic HL or diffuse large B cell lymphoma must have failed, refused or are ineligible to receive stem cell transplant;

4) Subjects must have measureable lesions (at least one target lesion measuring 2 cm in diameter) by computerized tomography (CT) scan;

5) Age >/= 18 years old;

6) Eastern Cooperative Oncology Group (ECOG) performance status 0-2

7) Adequate bone marrow, renal, and hepatic function, per local reference laboratory range as follows: 1) Absolute neutrophil count (ANC) >/= 1,000/mm^3; 2) Platelet count >/= 100,000/mm^3; 3) Hemoglobin >/= 9.0 g/dL; 4) Serum creatinine </= 1.5 g/dL or calculated creatinine clearance >/= 50; 5) AST and ALT </= 1.5 x institutional upper limit of normal (ULN) or </= 2.5 x ULN if liver involved by malignancy;

8) At least 4 weeks (from Day 1 of treatment) since prior chemotherapy, biological therapy, radiation therapy, major surgery, or other investigational or anti-cancer therapy that is considered disease-directed and has recovered from prior toxicities to Grade 0-1.

9) Has a corrected QT interval (QTc) </= 0.45 seconds using the Bazette Formula;

10) 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

11) Able to understand and willing to sign the informed consent form.

12) At least one week (from Day 1 of treatment) since prior treatment with CYP3A4 inducer/inhibitor

Exclusion Criteria:

1) Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, multiple myeloma, or HIV-associated lymphoma;

2) History of or active Central Nervous System (CNS) malignancy

3) Has undergone an allogeneic stem cell transplant and were treated with immunosupressing agent within the past 6 months;

4) Active Graft-versus-host disease (GVHD);

5) 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;

6) 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;

7) Known HIV-positive (such subjects are at increased risk of lethal infections when treated with potentially marrow-suppressive therapy);

8) Known active hepatitis A, B, or C;

9) Women who are pregnant or lactating.

Links

Registration Number: NCT00741871
Study Information on Clinical Trials Registry (clinicaltrials.gov)