MDACC Study Summary 2007-0965

Study Summary
No. 2007-0965:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2007-0965

Study Title:	A Phase 2 Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin Injection in Patients Greater than or Equal to 60 Years of Age with Previously Untreated Acute Myeloid Leukemia

Physician

New Patient Referral



Name:	Farhad Ravandi-Kashani	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-7305 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Sunesis Pharmaceuticals Inc.

Phase of Study:	Phase II	Return Visit:	Patients will be seen weekly while on study. Patients with a CR or CRp at the End-of-Treatment Visit return to the clinical site every 28±7 days for 1 year, then every 56+/-14 days thereafter for up to 1 year to confirm duration of response.

Treatment Agents:	Voreloxin	Home Care:	None

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

Estimated Length of Stay in Houston:	Hospitalization is not required for treatment. while on this study.


Description/ Intervention:	The goal of this clinical research study is to learn if voreloxin injection (voreloxin) (formerly known as SNS-595 injection) can help to control AML in patients 60 years of age and older who have not received any other treatment for cancer. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary Objective

The primary objective is to assess the overall remission rate (complete remission + complete remission with incomplete platelet recovery [CR+CRp]) voreloxin (voreloxin) (formerly known as SNS-595 Injection) in patients 60 years of age or older with previously untreated (de novo or secondary) acute myeloid leukemia (AML).

Secondary Objectives

The secondary objectives are as follows:
· To assess the safety of treatment with voreloxin Injection
· To assess leukemia-free survival (LFS), overall survival (OS), duration of response/remission (DR), and the 30- and 60-day all-cause mortality
· To characterize the pharmacokinetic (PK) profile of voreloxin Injection in this patient population
· To evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow (BM) samples before and after treatment with voreloxin ex vivo. Potential biomarkers will be correlated with clinical outcomes

Study Status Information



Study Activation / Registration Date:	05/02/2008

IRB Review and Approval Date:	05/02/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	60

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) Able to understand and to provide written informed consent

2) At least 60 years old and diagnosis of previously untreated AML subtype defined by the World Health Organization, except acute promyelocytic leukemia, who are unlikely to benefit from standard chemotherapy (defined as having one of the adverse prognostic factors in inclusion criterion no. 3): (a) must not have received prior therapy for AML including cytotoxic chemotherapy at any dose, antibody therapy, or other small molecule/targeted therapy, (b) may have received previous therapy for AHD (such as MDS), including azacytidine or decitabine, provided therapy was NOT given for treatment of AML

3) Must have at least one of the following adverse prognostic factors: (a) age greater than or equal to 70 years (b) antecedent hematologic disorder, (c) Eastern Cooperative Oncology Group performance status of 2, (d) intermediate or unfavorable (ie, adverse) karyotype defined as any cytogenetic profile except the presence of any of the following: (1) t(8;21)(q22;q22), (2) inv(16)(p13;q22)or t(16;16)(p13;q22), (3) t(15;17)(q22;q12) and variants

4) At least 20% blasts by BM biopsy or aspirate

5) Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2

6) Clinical laboratory values (based on local laboratory results) as follows: (a) Serum creatinine less than or equal to 1.5 times the upper limit of normal (ULN) or calculated creatinine clearance (CLCR) of greater than or equal to 50 mL/min, (b) Total bilirubin less than or equal to 1.5 x the upper limit of normal (ULN), unless due to Gilbert's syndrome, and (c) Aspartate aminotransferase (AST) and alkaline phosphatase less than or equal to 2.5 x ULN. Adequate cardiac function defined as a left ventricular ejection fraction (LVEF) greater than or equal to 40% by MUGA/echocardiogram.

Exclusion Criteria:

1) Disseminated intravascular coagulation

2) Active central nervous system involvement by AML

3) Other active malignancies or other malignancies within the last 12 months except nonmelanoma skin cancer or cervical intraepithelial neoplasia

4) History of myocardial infarction within the 3 months before the first voreloxin Injection

5) History of cerebrovascular accident/transient ischemic attack (CVA/TIA) within 3 months before Induction Day 1

6) Thromboembolic event (deep vein thrombosis [DVT] or pulmonary embolus [PE] within 28 days before Induction Day 1

7) Prior or current therapy: (a) Hydroxyurea within 24 hrs before first treatment with voreloxin Injection (b) treatment for AHD within 28 days before Induction Day 1 (c) treatment with an IMP within 28 days before Induction Day 1 (d) Persistent, clinically significant, chronic toxicities from prior AHD therapy or IMP treatment that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with study procedures

8) Requiring hemodialysis or peritoneal dialysis

9) Known allergy to D sorbitol or methanesulfonic acid

10) Prior exposure to voreloxin Injection

11) Females who are pregnant or breastfeeding

12) If applicable, females of childbearing potential or male partners of females of childbearing potential unwilling to use an approved, effective means of contraception according to the clinical site's standards (female patients of childbearing potential, excluding females who are surgically sterile or greater than 2 years postmenopausal must have a negative pregnancy test within 2 weeks prior to beginning treatment)

13) Any other medical, psychological, or social condition that, in the opinion of the PI or Medical Monitor or designee (Medical Monitor) would contraindicate the patient's participation in the clinical study due to safety or compliance with clinical study procedures

14) Antibiotic, antiviral, or antifungal treatment for an active infection within 7 days before Induction Day. Prophylactic antibiotics are acceptable.

Links

Registration Number: NCT00607997
Study Information on Clinical Trials Registry (clinicaltrials.gov)