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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cancer Neuroendocrine Tumors NET Adrenocortical Carcinoma ACC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TKM-080301

Group Type EXPERIMENTAL

TKM-080301

Intervention Type DRUG

Repeat dose IV infusion.

Interventions

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TKM-080301

Repeat dose IV infusion.

Intervention Type DRUG

Other Intervention Names

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PLK1 SNALP TKM-PLK1

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No