Status:
COMPLETED
Trial of RAD001 in Patients With Operable Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Emory University
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 to evaluate the target effects of this compounds on relevant molecular pathway...
Detailed Description
This is a Phase 1b pre-operative lung cancer trial wherein patients with operable lung cancer will be treated with RAD001 for 3-4 weeks to study the effects of the novel agent in relevant molecular pa...
Eligibility Criteria
Inclusion
- Patient must have histologically confirmed Stage I-IIIA non-small cell lung cancer (NSCLC) which is accessible to biopsy.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Life-expectancy greater than 6 months.
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function as defined in the protocol.
- Patient must be at least 18 years of age.
- Must meet pre-entry requirements for timing of study parameters as specified in section 7.0.
- Female patients of child-bearing potential must have a negative serum pregnancy test within 48 hours of study initiation and be non-lactating.
- Patients of child-bearing potential must agree to use an effective form of contraception while on study and for 3 months following completion of study treatment.
- The use of granulocyte-colony stimulating factor (G-CSF) will be permitted in study participants.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Exclusion
- Patient has received previous treatment for NSCLC.
- Known hypersensitivity to everolimus, sirolimus, or any of its excipients.
- Patient is pregnant or breast-feeding.
- Patient has incurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient is unable to swallow RAD001 tablet.
- History of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of the malignancy being present within the past five years.
- History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80. Symptoms may include any reaction such as bronchospasm, generalized urticaria, systolic BP ≤ 80mm Hg, and angioedema.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00401778
Start Date
November 1 2006
End Date
December 1 2013
Last Update
December 21 2016
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322