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
- Written Informed Consent.
- Males or females.
- 18-75 years.
- Histologically or cytologically confirmed non-estrogen dependent advanced solid
malignancy who has failed standard therapies and/or for which no curative therapeutic
option exists (phase I) or ;
- Histologically or cytologically confirmed NSCLC of stage IIIb or IV (phase IIa) that
has failed or is ineligible to standard therapies.
- One or more tumor lesions measurable by RECIST criteria
- Life expectancy of at least 3 months.
- ECOG performance of 2 or less.
- Prior decitabine or genistein therapy.
- Received cytotoxic agent, hormonal therapy, radiation therapy, or other targeted
cancer therapies or investigational agent within 4 weeks prior to study entry.
- Patients with confirmed estrogen receptor-positive cancers, or patients with a
primary breast or endometrial cancer for which phenotyping analysis has not been
- Presence of uncontrolled brain metastases or leptomeningeal disease.
- Uncontrolled cardiovascular disorders, including symptomatic heart failure, unstable
angina and cardiac arrhythmias.
- Inadequate baseline organ function as shown by following laboratory values :
- Hemoglobin < 90 g/L
- Absolute neutrophil count < 1,500 /microliter
- Platelet count < 100,000 /microliter
- Total bilirubin > 1.5 ULN
- AST and ALT > 2.5 ULN
- Creatinine clearance < 60 ml/min
- To be dependent of oxygen treatment.
- Active infections requiring antibiotics.
- Pregnancy or breastfeeding. All women of child-bearing potential must have a negative
pregnancy test prior to first receiving protocol therapy.
- Known allergic reactions to soy derivatives or deoxycytidine derivatives.
- Active alcohol or drug abuse.
- Any co-morbid condition that in the judgment of the investigator renders the subject
at high risk of treatment complication or reduces the probability of assessing
- Other malignancies diagnosed within the last 5 years with the exception of Basal Cell
Carcinoma of the skin.
- Gastrointestinal disorders or abnormalities that may interfere with the absorption of
- Patients unable to comply with the study protocol and follow-up schedule for any
psychological, familial, sociological or geographical reason.