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

This study is currently recruiting participants.
Verified September 2012 by Tekmira Pharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01262235
First received: December 15, 2010
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: TKM-080301
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Tekmira Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Safety and tolerability of treatment with TKM-080301 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics of TKM-080301 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Assess preliminary evidence of anti-tumor activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: December 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKM-080301 Drug: TKM-080301
Repeat dose IV infusion.
Other Names:
  • PLK1 SNALP
  • TKM-PLK1

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01262235

Contacts
Contact: Ian MacLachlan, PhD 604-419-3205 imaclachlan@tekmirapharm.com

Locations
United States, Arizona
Scottsdale Healthcare Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Ramesh Ramanathan, MD            
Mayo Clinic Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Donald W Northfelt, MD            
Sponsors and Collaborators
Tekmira Pharmaceuticals Corporation
Investigators
Study Director: Ian MacLachlan, PhD Tekmira Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01262235     History of Changes
Other Study ID Numbers: TKM-PLK1-001
Study First Received: December 15, 2010
Last Updated: September 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Tekmira Pharmaceuticals Corporation:
Solid tumor
Non-Hodgkin's Lymphoma
Hodgkin's Disease

ClinicalTrials.gov processed this record on May 19, 2013