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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

Phase 1/Phase 2
18 Years
75 Years
Open (Enrolling)
Non Small Cell Lung Cancer

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Trial Information

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

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
clinical effect.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

MTD determination will based on the incidence of reported adverse events (including dose-limiting toxicities) and abnormal laboratory test results.

Outcome Time Frame:

28 day treatment cycle for MTD assessment; 4-6 cycles to be administered

Safety Issue:


Principal Investigator

Normand Blais, MD, FRCP(C)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Notre Dame du CHUM


Canada: Health Canada

Study ID:




Start Date:

November 2012

Completion Date:

December 2013

Related Keywords:

  • Non Small Cell Lung Cancer
  • Phase I b : advanced solid malignancy
  • Phase II a: stage III b or IV, Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms