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

NCT01262235 | Completed Phase 1 DMC

• 1 other identifier: TKM-PLK1-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 8

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.

Conditions

Cancer; Neuroendocrine Tumors; NET; Adrenocortical Carcinoma; ACC

Keywords

Solid tumor; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Neuroendocrine tumors (NET); Adrenocortical carcinoma (ACC); Carcinoid

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability of treatment with TKM-080301

  6 months

• Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301

  6 months

Secondary Outcomes (2)

• Characterize the pharmacokinetics of TKM-080301

  2 months

• Assess preliminary evidence of anti-tumor activity

  6 months

Study Arms (1)

TKM-080301

EXPERIMENTAL

Drug: TKM-080301

Interventions

TKM-080301 DRUG

Repeat dose IV infusion.

Also known as: PLK1 SNALP, TKM-PLK1

TKM-080301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arbutus Biopharma Corporation: lead

Study Sites (8)

Scottsdale Healthcare Research Institute

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-2800, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Westchase Oncology Center

Houston, Texas, 77042, United States

Location

MeSH Terms

Conditions

Neoplasms; Neuroendocrine Tumors; Adrenocortical Carcinoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Carcinoid Tumor

Interventions

TKM-080301

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Adrenal Cortex Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mark Kowalski, MD

  Tekmira Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

US (8)