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

Primary Purpose

Cancer, Neuroendocrine Tumors, NET

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TKM-080301
Sponsored by
Arbutus Biopharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Solid tumor, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Neuroendocrine tumors (NET), Adrenocortical carcinoma (ACC), Carcinoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scottsdale Healthcare Research Institute
  • Mayo Clinic Arizona
  • Moffitt Cancer Center
  • University of Iowa/Holden Comprehensive Cancer Center
  • Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Mayo Clinic
  • Westchase Oncology Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TKM-080301

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability of treatment with TKM-080301
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301

Secondary Outcome Measures

Characterize the pharmacokinetics of TKM-080301
Assess preliminary evidence of anti-tumor activity

Full Information

First Posted
December 15, 2010
Last Updated
January 14, 2019
Sponsor
Arbutus Biopharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01262235
Brief Title
A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arbutus Biopharma Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Neuroendocrine Tumors, NET, Adrenocortical Carcinoma, ACC
Keywords
Solid tumor, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Neuroendocrine tumors (NET), Adrenocortical carcinoma (ACC), Carcinoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TKM-080301
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TKM-080301
Other Intervention Name(s)
PLK1 SNALP, TKM-PLK1
Intervention Description
Repeat dose IV infusion.
Primary Outcome Measure Information:
Title
Safety and tolerability of treatment with TKM-080301
Time Frame
6 months
Title
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Characterize the pharmacokinetics of TKM-080301
Time Frame
2 months
Title
Assess preliminary evidence of anti-tumor activity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Kowalski, MD
Organizational Affiliation
Tekmira Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Healthcare Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2800
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Westchase Oncology Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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