MDACC Study Summary 2010-0492

Study Summary
No. 2010-0492:.......Lymphoma......Michelle A. Fanale......Lymphoma/Myeloma

Study Summary Title



Study Summary Number:	2010-0492

Study Title:	A Phase 2 Safety and Efficacy Study of SB1518 for the Treatment of Advanced Lymphoid Malignancies

Physician

New Patient Referral



Name:	Michelle A. Fanale	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:	713-792-2806 Contact us about clinical trials

General Information



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

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	SB1518	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if SB1518 can help to control lymphoid cancer. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary Objective:
• Assess the efficacy of SB1518 in the treatment of patients with advanced lymphoid malignancies including Hodgkin Lymphoma, Mantle Cell Lymphoma and Indolent Lymphoma (follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma and small lymphocytic lymphoma).
Secondary Objectives:
• Assess the durability of response and progression-free survival (PFS) following SB1518 treatment in patients with advanced lymphoid malignancies.
• Assess the safety and tolerability of SB1518 administered orally once daily at 400 mg in patients with advanced lymphoid malignancies.

Study Status Information



Study Activation / Registration Date:	12/16/2010

IRB Review and Approval Date:	12/16/2010

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	87

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) Patients with histologically documented diagnosis of one of the following lymphoid malignancies: - Hodgkin Lymphoma; - Mantle Cell Lymphoma - Indolent Lymphoma (including follicular lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and small lymphocytic lymphoma)

2) Patients must have received at least one prior treatment regimen. Patients with Hodgkin Lymphoma must have either received an autologous stem cell transplant, refused or been deemed ineligible for an autologous stem cell transplant;

3) Patients must have measurable lesions (at least one target lesion measuring 2 cm in diameter) by computerized tomography (CT) scan;

4) Age >/= 18 years old;

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

6) Adequate bone marrow, renal, and hepatic function, per local reference laboratory ranges as follows: o Absolute neutrophil count (ANC) >/= 1,000/mm3; o Platelet count >/= 75,000/mm3; o Hemoglobin >/= 9.0 g/dL; o Serum creatinine </= 2.0 g/dL or calculated creatinine clearance >/= 60mL/min; o AST and ALT </= 2.5 x institutional upper limit of normal (ULN) or </= 5 x ULN if liver involved by malignancy;

7) At least 2 weeks since prior chemotherapy, biological therapy, radiation therapy, major surgery, other investigational, or anti-cancer therapy that is considered diseasedirected and recovered from prior toxicities to Grade 0-1

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

9) 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;

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

Exclusion Criteria:

1) Any histology other than Hodgkin Lymphoma, Mantle Cell Lymphoma or Indolent Lymphoma;

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

3) Allogeneic stem cell transplant within the past 6 months;

4) Ongoing need for treatment with immunosuppressive therapy for management of post-allogeneic stem cell transplant complications (i.e., GVHD);

5) Active graft-versus-host disease (GVHD);

6) Uncontrolled inter-current illness including, but not limited to, ongoing active infection or psychiatric illness/social situations that would limit compliance with study requirements as judged by treating physician. Patients receiving antibiotics for infections that are under control may be included in the study;

7) Clinically symptomatic and uncontrolled cardiovascular disease;

8) Ongoing cardiac dysrhythmias of Grade >/= 2, atrial fibrillation of any grade, prolongation of the QTc > 470 msec or other factors that increase the risk of QT prolongation or (e.g., heart failure, hypokalemia defined as serum potassium < 3.0 mEq/L, family history of long QT interval syndrome);

9) New York Heart Association Class III or IV congestive heart failure;

10) History of myocardial infarction, severe/unstable angina or symptomatic congestive heart failure, within the 6 months prior to study drug administration;

11) Require the use of a concomitant medication that is known to prolong QT interval;

12) Patients with a history of any malignancy except early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia, unless they have been in remission for >/= 2 years;

13) Known HIV-positive;

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

15) Women who are pregnant or lactating.

Links

Registration Number: NCT01263899
Study Information on Clinical Trials Registry (clinicaltrials.gov)