Open label, non-randomized, phase 2 Study investigating the effect of RAD001 monotherapy in patients with advanced NSCLC previously treated with either chemotherapy only or with chemotherapy and EGFR inhibitor(s) - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-003018-41-DE
• Date of registration: 02/06/2006
• Prospective Registration: No
• Primary sponsor: Novartis Pharma Services AG
• Public title: Open label, non-randomized, phase 2 Study investigating the effect of RAD001 monotherapy in patients with advanced NSCLC previously treated with either chemotherapy only or with chemotherapy and EGFR inhibitor(s) - N/A
• Scientific title: Open label, non-randomized, phase 2 Study investigating the effect of RAD001 monotherapy in patients with advanced NSCLC previously treated with either chemotherapy only or with chemotherapy and EGFR inhibitor(s) - N/A
• Date of first enrolment: 18/08/2005
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-003018-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany, Italy

Key inclusion & exclusion criteria

Inclusion criteria:
• Patients with advanced (unresectable or metastatic) NSCLC
• Patients must have at least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation.
• Patients who have received = 2 chemotherapy regimen, one of which must have included cisplatinum or carboplatin, and who have documented evidence of tumor progression (Arm 1)Patients who have received chemotherapy and small molecule EGFR inhibitor (as a separate regimen) with documented tumor progression despite at least 4 weeks therapy with either gefitinib or erlotinib (Arm 2)
• Serial CT scans demonstrating progressive disease according to RECIST must be available
• Pathologic confirmation of NSCLC with a tissue sample of the metastatic or primary tumor available for molecular marker analyses
• Age = 18 years
• Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy).
• WHO performance status £ 2
• Adequate bone marrow function as shown by: ANC = 1.5 x 109/L, Platelets = 100 x 109/L, Hgb > 9 g/dL
• Adequate liver function as shown by: serum bilirubin = 1.5 x upper limit of normal (ULN), and serum transaminases activity = 3 x ULN. With the exception of serum transaminases (< 5 x ULN) if the patient has liver metastases
• Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
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

Exclusion criteria:
• Concurrent therapy with agents used other than as anticancer therapy (for example, methotrexate for rheumatoid arthritis)
• Any investigational drug, other than EGFR inhibitor (Arm 2), within the preceding
4 weeks
• Chronic treatment with steroids or another immunosuppressive agent
• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
• Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
• A known history of HIV seropositivity
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
• Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001)
• History of noncompliance to medical regimens
• Patients unwilling to or unable to comply with the protocol


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Lung cancer is one of the most common malignancies in developed countries and accounts for millions of deaths worldwide. In 2000, the annual incidence of non-small cell lung cancer (NSCLC), which comprises 80% of all lung cancer cases, was 991,089 and the worldwide mortality was 882,495. Unfortunately, two-thirds of NSCLC patients have advanced disease (clinical stage IIIB/IV) and are considered incurable by surgery or chest radiation.

Intervention(s)

Product Name: RAD001
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Current Sponsor code: RAD001
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

Secondary Objective: • To assess the safety of RAD001 monotherapy
• To assess additional clinical efficacy of RAD001, based on rate of early disease progression (EPR)
• To assess the steady state levels of RAD001 in blood
• To investigate potential molecular markers predictive of clinical effect

Primary end point(s): objective tumor response rate (RR)

Main Objective: To assess the clinical efficacy of RAD001, based on the evaluation of objective tumor response rate (RR)

Secondary ID(s)

CRAD001C2235

N/A