A Study to Determine Safety, Pharmacokinetics and Pharmacodynamics of Intravenous TKM 080301 in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tekmira Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01262235
First received: December 15, 2010
Last updated: August 27, 2015
Last verified: August 2015
  Purpose

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 Intervention Phase
Cancer
Neuroendocrine Tumors
NET
Adrenocortical Carcinoma
ACC
Drug: TKM-080301
Phase 1
Phase 2

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 1/2 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 ]

Enrollment: 68
Study Start Date: December 2010
Study Completion Date: August 2015
Primary Completion Date: July 2015 (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. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Scottsdale Healthcare Research Institute
Scottsdale, Arizona, United States, 85258
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
Tekmira Pharmaceuticals Corporation
Investigators
Study Director: Mark Kowalski, MD 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: August 27, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Tekmira Pharmaceuticals Corporation:
Solid tumor
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Neuroendocrine tumors (NET)
Adrenocortical carcinoma (ACC)
Carcinoid

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Apudoma
Carcinoid Tumor
Carcinoma
Neuroendocrine Tumors
Adenocarcinoma
Adenoma
Adrenal Cortex Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Diseases
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on August 27, 2015