An Open-Label, Multicenter Dose-Escalation Study to Evaluate the Safety and Tolerability of AP 12009 (Trabedersen), Administered Intravenously in Patients With Advanced Tumors Known to Overproduce TGF-β2.
The purpose of this dose-finding study is to evaluate the safety and tolerability of AP
12009. Two fixed dose-escalation schemes with predefined steps and increasing increments
have been selected to determine the maximum tolerated dose (MTD) as well as the
dose-limiting toxicity (DLT). At least two cycles of AP 12009 are administered intravenously
in adult patients with no further acknowledged treatment options.
AP 12009 (trabedersen) is a phosphorothioate antisense oligodeoxynucleotide specific for the
mRNA of human Transforming Growth Factor beta 2 (TGF-beta-2). The growth factor TGF-beta
plays a key role in malignant progression of various tumors by inducing proliferation,
invasion, metastasis, angiogenesis, and escape from immunosurveillance. In patients with
pancreatic cancer, colorectal cancer, and metastatic melanoma the TGF-beta-2 overexpression
is associated with disease stage, clinical prognosis, and the immunodeficient state of the
patients.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD) as well as the dose-limiting toxicity (DLT) of two cycles of AP 12009 administered intravenously at weekly intervals and for four days every other week.
Yes
Helmut Oettle, MD
Study Chair
Charité Berlin Campus Virchow-Klinikum
Germany: Federal Institute for Drugs and Medical Devices
AP 12009-P001
NCT00844064
January 2005
November 2011
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