Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000218493
Ethics application status
Approved
Date submitted
16/04/2007
Date registered
20/04/2007
Date last updated
20/04/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to test an oral combination of letrozole and everolimus for patients with advanced lung cancer who have progressed on first line chemotherapy.
Scientific title
Phase II Study Evaluating Efficacy and Safety of Everolimus with Letrozole for Management of Advanced (unresectable or metastatic) Non Small Cell Lung Cancer (NSCLC) after Failure of Platinum-Based Treatment
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell lung cancer 1746 0
Condition category
Condition code
Cancer 1837 1837 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with metastatic non small cell lung cancer who have previously failed on platinum based chemotherapy will be treated on a daily oral combination of letrozole 2.5 mg and everolimus 10mg. The patients will be assessed on a regular basis with CT-PET scan. The first assessment will be after 4 weeks. Subsequent scans will be at 8 weeks interval. Patients will continue the treatment till they are having benefit.
Intervention code [1] 1703 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2576 0
Response rate
Timepoint [1] 2576 0
Once at week 4 after starting treatment by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
Secondary outcome [1] 4432 0
• Progression free survival- time from signing consent to an event (death from any cause or disease progression).
Timepoint [1] 4432 0
Monitored 4 weekly
Secondary outcome [2] 4433 0
• Overall survival defined as time between signing consent to death from any cause.
Timepoint [2] 4433 0
Monitored 4 weekly
Secondary outcome [3] 4434 0
• Side effects & quality of life.
Timepoint [3] 4434 0
Monitored on 4 weekly basis till 4 weeks after stopping treatment
Secondary outcome [4] 4435 0
• Correlation of outcomes with baseline genomic profile.
Timepoint [4] 4435 0
Assessed at week 4 after starting treatment.

Eligibility
Key inclusion criteria
1. Histologically or cytologically proven diagnosis of non-small cell lung cancer of either gender. 2. Age > 18 years for males. Females should be post-menopausal, which is defined as:• Prior oopherectomy, or • 12 month-history of amenorrhoea, or • FSH (Follicle Stimulating Hormone) and LH (Luteinizing Hormone) in post-menopausal range. There is no upper age limit. 3. performance status = 2.4. Adequate organ function• Hematological- Hb> 90 g/L, Absolute Neutrophil Count = 1.5 x 109/L, platelets = 100 x 109/L.• Liver functions- bilirubin = 2 x upper limit normal (ULN), Aspartate Aminotransferase /Alanine Aminotransferase/ Alkaline Phosphatase = 2.5 x ULN or = 5 x ULN in presence of liver metastases, S. albumin = 30 g/L.• Renal function- Creatinine = 2 ULN, Creatinine clearance > 30 mL/min. 6. Patients should stop any hormonal medication as hormone replacement therapy or progesterone at least one month prior to enrolment. 7. Patients should have at least one measurable lesion by RECIST criteria.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Untreated brain metastases. 2. Patients on strong inhibitor or inducer of isoenzyme CYP3A. 3. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections. 4. Uncontrolled diabetes.5.Patients with grade 3 hypercholesterolemia / hypertriglyceridemia or = grade 2 hypercholesterolemia / hypertriglyceridemia with history of coronary artery disease (despite lipid lowering treatment if given)6. Previous treatment with mTOR inhibitors and/or known hypersensitivity to mTOR inhibitors.7. A known history of Human Immunodeficiency Virus or previous seropositivity for the virus.8. Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture).9. Patients will be excluded if they are on raloxifene or tamoxifen. 10. Patients who have an impairment of gastrointestinal function or who havegastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1987 0
Commercial sector/Industry
Name [1] 1987 0
Novartis Pharmaceuticals Pty Ltd
Country [1] 1987 0
Primary sponsor type
Hospital
Name
Dept of Medical Oncology, Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 1799 0
None
Name [1] 1799 0
None
Address [1] 1799 0
Country [1] 1799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3692 0
Royal Adelaide Hospital
Ethics committee address [1] 3692 0
Ethics committee country [1] 3692 0
Australia
Date submitted for ethics approval [1] 3692 0
Approval date [1] 3692 0
14/09/2006
Ethics approval number [1] 3692 0
060717

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27806 0
Address 27806 0
Country 27806 0
Phone 27806 0
Fax 27806 0
Email 27806 0
Contact person for public queries
Name 10892 0
Dr Nimit Singhal
Address 10892 0
Department of Medical Oncology
Level 7 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 10892 0
Australia
Phone 10892 0
+61 8 82224398
Fax 10892 0
+61 8 82224358
Email 10892 0
nsinghal@mail.rah.sa.gov.au
Contact person for scientific queries
Name 1820 0
Dr Nimit Singhal
Address 1820 0
Department of Medical Oncology
Level 7 East Wing
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 1820 0
Australia
Phone 1820 0
+61 8 82224398
Fax 1820 0
+61 8 82224358
Email 1820 0
nsinghal@mail.rah.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.