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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01262235
Other study ID # TKM-PLK1-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2010
Est. completion date August 2015

Study information

Verified date January 2019
Source Arbutus Biopharma Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date August 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
TKM-080301
Repeat dose IV infusion.

Locations

Country Name City State
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Dana Farber Cancer Institute Boston Massachusetts
United States Westchase Oncology Center Houston Texas
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Mayo Clinic Rochester Minnesota
United States Mayo Clinic Arizona Scottsdale Arizona
United States Scottsdale Healthcare Research Institute Scottsdale Arizona
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Arbutus Biopharma Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability of treatment with TKM-080301 6 months
Primary Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301 6 months
Secondary Characterize the pharmacokinetics of TKM-080301 2 months
Secondary Assess preliminary evidence of anti-tumor activity 6 months
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