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Investigator(s):
Shivaani Kummar, M.D., F.A.C.P. Principal Investigator Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Referral Coordinator Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Lemual Clayborn Referral Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov	Jennifer Zlott, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-435-5664 Fax: 301-480-7281 zlottjh@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed diagnosis of a solid tumor
• Disease must be amenable to biopsy, and patients must be willing to undergo tumor biopsies
• Failed at least one line of prior therapy for metastatic disease or have a disease for which no standard curative therapy exists
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• AST/ALT ≤ 2.5 x ULN
• Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 60 mL/min for patients with creatinine levels above 1.5 x ULN
• INR ≤ 1.4 and PTT ≤ 36 seconds
• Not pregnant or breastfeeding

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Study Outline:

• EZN-2968 will be administered IV (through a vein) once a week for 3 consecutive weeks followed by a 3-week period without the drug (6-week cycle)
• Tumor biopsies and other correlative imaging and pharmacodynamic studies will be performed at baseline and after the third dose
• Tumor restaging will be performed every two cycles
• Cycles continue in the absence of disease progression or unacceptable toxicity

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 9/25/12