Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01262235
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Arbutus Biopharma Corporation

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 17, 2010
Last Update Posted Date January 16, 2019
Study Start Date  ICMJE December 2010
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Safety and tolerability of treatment with TKM-080301 [ Time Frame: 6 months ]
  • Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301 [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01262235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Characterize the pharmacokinetics of TKM-080301 [ Time Frame: 2 months ]
  • Assess preliminary evidence of anti-tumor activity [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
Official Title  ICMJE A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Neuroendocrine Tumors
  • NET
  • Adrenocortical Carcinoma
  • ACC
Intervention  ICMJE Drug: TKM-080301
Repeat dose IV infusion.
Other Names:
  • PLK1 SNALP
  • TKM-PLK1
Study Arms  ICMJE Experimental: TKM-080301
Intervention: Drug: TKM-080301
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2015)
68
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2010)
42
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262235
Other Study ID Numbers  ICMJE TKM-PLK1-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arbutus Biopharma Corporation
Study Sponsor  ICMJE Arbutus Biopharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Kowalski, MD Tekmira Pharmaceuticals
PRS Account Arbutus Biopharma Corporation
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP