Dose Escalation Study to Determine Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301

Location:

Phoenix/Scottsdale, AZ.

Trial status:

Open for Enrollment

Why is this study being done?

This study will be a Phase I, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy.

Who is eligible to participate?

Inclusion Criteria:

         -  Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist,

         -  Patient has an ECOG performance status of 0 - 1,

         -  Patient has adequate hematologic, hepatic and renal function,

         -  Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV),

         -  Patients must have a life expectancy of at least 12 weeks.

       Exclusion Criteria:

         -  Unresolved toxicities (> Grade 1) of previous chemotherapy,

         -  Patients with primary tumors of the central nervous system (CNS),

         -  Prophylactic hematologic growth factors administered </= 2 weeks prior to start of therapy,

         -  Patient has history of or existing clinically significant cardiovascular disease,

         -  Patient has a seizure disorder not controlled on medication,

         -  Patient has a known or suspected viral, parasitic, or fungal infection,

         -  Patient has known hypersensitivity or previous severe reactions to oligonucleotide- or lipid-based products, including liposomal drug products and phospholipid-based products,

         -  Patient has been treated with any investigational drugs, biologics, or devices within 28 days prior to study treatment.

Last updated:

9/26/2012

NCT ID:

NCT01262235

IRB Number:

11-000470