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



Status:Completed
Conditions:Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:December 2010
End Date:August 2015

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A Phase 1/2 Dose Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301 in Patients With Advanced Solid Tumors

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.


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 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.
We found this trial at
8
sites
Rochester, Minnesota 55905
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Houston, Texas 77042
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Houston, TX
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Iowa City, IA
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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Scottsdale, Arizona 85258
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Scottsdale, AZ
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Tampa, Florida 33612
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Tampa, FL
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