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A Phase 1 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

A Phase 1 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors


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 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of treatment with TKM-080301

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Ian MacLachlan, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Tekmira Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

TKM-PLK1-001

NCT ID:

NCT01262235

Start Date:

December 2010

Completion Date:

July 2013

Related Keywords:

  • Cancer
  • Solid tumor
  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease

Name

Location

Mayo Clinic Arizona Scottsdale, Arizona  85259
Scottsdale Healthcare Research Institute Scottsdale, Arizona  85258