Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase I/IIa Dose-Escalation Study of the Decitabine-Genistein Drug Combination in Advanced Solid Tumors and Non-Small Cell Lung Cancer (NSCLC) Subjects
Lung cancer is one of the most prevalent and lethal neoplasias in the world. Currently used
chemotherapy regimens have been disappointing in improving overall survival. Decitabine is a
S-phase pyrimidine analog that induces DNA hypomethylation. This drug is currently used to
treat Myelodysplastic Syndrome ( MDS) and has been studied for the treatment of leukemia.
Genistein, is a soy extracted non-toxic isoflavone and phytoestrogen, which has been shown
to inhibit activity of cell signaling pathways, such as those driven by tyrosine kinases.
Results from in vitro experiments unambiguously demonstrated that the combination of these
two compounds induces a synergistic reduction of the multiplication of lung, colon, breast
and leukemic cancer cells. Consequently, clinical evaluation of this drug combination is
warranted in Non Small Cell Lung Cancer ( NSCLC), and it is hypothezised that this new
regimen will safely improve overall tumor response rate and cancer progression free
survival.
The proposed trial is a two part study: The phase I part is an open-label, dose-escalation
evaluation in subjects with advanced solid tumors who have failed standard therapies and for
whom no curative therapeutic option exists.
A cohort of three subjects will be treated per dose level. One cycle is 28 days. Five
different, increasing dose levels ranging from 60 mg/m2 to 500 mg/m2 of IV decitabine
combined with a fixed oral dose of 150 mg BID of genistein will be tested. The Maximum
Tolerated Dose (MTD) will be determined based on the occurrence of Dose Limiting Toxicities
(DLTs).
In the phase IIa part of the study, only Stage IIIb and IV advanced NSCLC patients will be
treated at the recommended decitabine MTD dose combined with genistein. Safety and
preliminary efficacy will be assessed. It is expected that a maximum sample of 46 patients
will be enrolled in this trial.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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