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Clinical Trials/EUCTR2004-003017-16-FR
EUCTR2004-003017-16-FRActive, not recruitingNot Applicable

A combined phase 1 and 2 study investigating the combination of RAD001 and erlotinib in patients with advanced NSCLC previously treated only with chemotherapy - N/A

ovartis Pharma Services AG0 sites180 target enrollmentStarted: November 28, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
180
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients with advanced NSCLC (unresectable or metastatic)
  • •Age = 18 years old
  • •Pathologic confirmation of NSCLC
  • •Tumor tissue samples (paraffin block or unstained slides) must be available for central analysis of molecular markers for those patients entered on the Phase 2 part of the study. If possible, tumor tissue samples should be available for patients enrolled in Phase 1 part of the study
  • •Patients entered on the phase 2 of the study 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 must have been treated with chemotherapy for advanced disease and have documented tumor progression (serial CT scans demonstrating progressive disease according to RECIST must be available) despite = 2 chemotherapy schedules for treatment of advanced disease (previous therapy for localized disease is not counted), one of which must have included cisplatin or carboplatin
  • •More than two weeks since any major surgery, completion of radiation, or completion of all prior chemotherapy (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 = grade 2 and 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

  • •Patients will be excluded if they meet ANY of the following criteria:
  • •Concurrent therapy with agents otherwise used in treatment of cancer (for example, methotrexate for rheumatoid arthritis)
  • •Treatment with any other investigational drugs within the preceding 4 weeks
  • •Prior treatment with an EGFR inhibitor (either a small molecule EGFR TK inhibitor or ant-EGFR antibody)
  • •Chronic treatment with steroids or another immunosuppressive agent
  • •Leptomeningeal or uncontrolled brain metastases, including patients who continue to require glucocorticoids or intrathecal chemotherapy for brain or leptomeningeal metastases (documented by lumbar puncture)
  • •Malignancies other than lung cancer within the past 2 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 or previous seropositivity for the virus
  • •Patients with active skin, mucosa, ocular or GI disorders of grade > 1
  • •Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 or erlotinib (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 coumadin)
  • •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 or erlotinib)
  • •History of noncompliance to medical regimens
  • •Patients unwilling to or unable to comply with the protocol

Investigators

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