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A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy


Phase 1
23 Years
76 Years
Not Enrolling
Both
Non Small Cell Lung Cancer

Thank you

Trial Information

A Two-step Phase 1 Study Investigating the Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients Not Treated Previously With Systemic Therapy


This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001
is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as
carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced
(unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced
disease

Inclusion Criteria


Inclusion criteria:

- Age over 18 years

- Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)

- Ability to perform normal daily functions

Exclusion criteria:

- Chronic steroid treatment

- Prior treatment with chemotherapy for advanced lung cancer

- Prior treatment with mTOR inhibitors

- Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth
ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes,
infections or other severe medical conditions

- Known sensitivity to platinum compounds, taxanes or bevacizumab

- Other cancers within the past 5 years

- Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria
may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate

Outcome Time Frame:

Ever 3 months or once a critical DLT occurs

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2114

NCT ID:

NCT00457119

Start Date:

February 2007

Completion Date:

November 2009

Related Keywords:

  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer
  • NSCLC
  • Advanced Lung Cancer
  • RAD
  • RAD001
  • chemotherapy
  • carboplatin
  • paclitaxel
  • bevacizumab
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center New Orleans, Louisiana  70115
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office Dallas, Texas  75390-9151
Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114 Washington, District of Columbia  20007-2197
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc. Houston, Texas  77030-4009