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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262235
• Other study ID #: TKM-PLK1-001
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• ACC
• Adrenocortical Carcinoma
• Cancer
• Carcinoma
• NET
• Neuroendocrine Tumors

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