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A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01262235
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : January 16, 2019
Information provided by (Responsible Party):
Arbutus Biopharma Corporation

Brief Summary:
This study will be a Phase I/II, 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. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.

Condition or disease Intervention/treatment Phase
Cancer Neuroendocrine Tumors NET Adrenocortical Carcinoma ACC Drug: TKM-080301 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors
Study Start Date : December 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: TKM-080301 Drug: TKM-080301
Repeat dose IV infusion.
Other Names:
  • TKM-PLK1

Primary Outcome Measures :
  1. Safety and tolerability of treatment with TKM-080301 [ Time Frame: 6 months ]
  2. Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301 [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Characterize the pharmacokinetics of TKM-080301 [ Time Frame: 2 months ]
  2. Assess preliminary evidence of anti-tumor activity [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC 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.
  • 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 history of clinically significant asthma or COPD requiring daily medication within the last 6 months,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01262235

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United States, Arizona
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States, 85258
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Iowa
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-2800
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Texas
Westchase Oncology Center
Houston, Texas, United States, 77042
Sponsors and Collaborators
Arbutus Biopharma Corporation
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Study Director: Mark Kowalski, MD Tekmira Pharmaceuticals
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Responsible Party: Arbutus Biopharma Corporation Identifier: NCT01262235    
Other Study ID Numbers: TKM-PLK1-001
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Keywords provided by Arbutus Biopharma Corporation:
Solid tumor
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Neuroendocrine tumors (NET)
Adrenocortical carcinoma (ACC)
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Adrenocortical Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action