An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.
- Conditions
- extensive disease, small cell lungcancer (ED-SCLC)MedDRA version: 14.1Level: PTClassification code 10041071Term: Small cell lung cancer stage unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-004566-13-IT
- Lead Sponsor
- MERCK KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
? Signed written informed consent
? ≥18 years of age
? Histologically documented SCLC
? Radiologically demonstrated extensive-stage
disease by thoracic and abdominal CT or MRI
scan prior to induction chemotherapy
? Received 4 cycles of platinum-based, first-line
chemotherapy (12-14 weeks) without thoracic
irradiation
? Experienced a response to platinum-based,
first-line chemotherapy (CR or PR according to
RECIST shown after second and fourth course
of induction chemotherapy compared to
findings prior to induction therapy)
? Confirmatory CT or MRI scan
? Negative CT scan of the head
? Be enrolled and begin treatment 3-5 weeks after
last infusion of platinum-based, first-line
chemotherapy
? Life expectancy ≥4 months
? ECOG performance status ≤2 at study entry
? No clinical history of significantly impaired
renal function or chronic kidney disease. Must
have an estimated glomerular filtration rate ≥50
mL/min determined by the Cockgraft-Gault
formula No significant haematologic abnormalities,
including white blood cell count ≥2.5 × 103/μl
(or total granulocytes ≥1 × 103/μl), absolute
lymphocyte count ≥0.5 × 103/μl, platelet count
≥100 000/μl, and haemoglobin level >5.5
mmol/L
? No significant hepatic abnormalities, including
alanine aminotransaminase and aspartate
aminotransaminase ≤2.5 × the upper limit of
normal (ULN), or ≤5 × ULN in case of liver
metastasis, and total bilirubin <1.5 × ULN
? No significant electrolyte abnormalities,
including serum sodium, potassium, and
phosphorus within normal limits
? Serologic testing within 4 weeks prior to
starting study treatment with negative results
for hepatitis C virus (HCV), human
immunodeficiency virus (HIV), and hepatitis B
virus (HBV) demonstrated by negative hepatitis
B core antibody (HBcAb) and hepatitis surface
antigen (HbsAg)
? Negative urine β-HCG pregnancy test and
willingness to use effective contraception for
both male and female subjects for the study
duration and 1 month thereafter if of
procreative potential; non-lactating females
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? Thoracic radiotherapy, surgery (excluding prior
diagnostic biopsy) or any investigational drug
in the 30 days before the start of treatment in
this study
? ECG with evidence of active clinically
significant cardiac disease within 4 weeks prior
to starting study treatment and/or a cardiac
stress test with abnormal results in subjects who
have a history of signficant coronary heart
disease (MI, angina pectoris, or high risk of
uncontrolled arrhythmia)
? Uncontrolled CHF New York Heart
Association Grade 2-4 or echocardiogram with a left ventricular ejection fraction <45%, or
other signs of active clinically significant
cardiovascular disease
? History of repeated and clinically relevant
episodes of syncope or other paroxysmal,
ventricular, or other clinically significant
arrhythmias unless controlled by an automatic
internal cardiac defibrillator
? Uncontrolled hypertension (systolic blood
pressure ≥180 mmHg or diastolic blood
pressure ≥100 mmHg) or hypotension (systolic
blood pressure ≤80 mmHg requiring therapy
beyond 24 hours)
? Evidence of active brain metastases
? No past history of neoplasm other than lung
carcinoma, except for curatively treated nonmelanoma
skin cancer, in situ carcinoma of the
cervix or other cancer curatively treated and
with no evidence of disease for at least 5 years.
? Presence of medically significant third space
fluids such as pleural or pericardial effusions or
ascites requiring repetitive paracentesis, or
oedema ≥Grade 2 according to the National
Cancer Institute Common Terminology Criteria
for Adverse Events (NCI CTCAE) Version 3.0
? Previous diagnosis of autoimmune disease
involving major organ system or requirement
for immunosuppressive therapy
? History of inflammatory bowel disease or
history of acute or chronic bowel ischemia
? Significant active infection
? Legal incapacity or limited legal capacity that
would interfer with informed consent or impair
participation in the study
? Known hypersensitivity to Tween-80TM, human
immunoglobulin, CTX, or any of the
components of study treatments
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method