Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients

Novartis Pharmaceuticals69 enrolled

Overview

This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

RAD001DRUG

5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm

Eligibility

Sex: ALLMin age: 23 YearsMax age: 76 Years

Medical Language ↔ Plain English

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

Locations (8)

Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114

Washington D.C., District of Columbia, United States

LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center

New Orleans, Louisiana, United States

U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Ever 3 months or once a critical DLT occurs

Secondary Outcomes

Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)

Time frame: End of step 1

Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)

Time frame: End of Step 2

PK parameters derived from PK profiles of treatment drugs alone and in combination

Time frame: End of Step 1 and Step 2

Best overall response - measured by CT/MRI scan every 6-8 week

Time frame: Every 6-8 week

Data from ClinicalTrials.gov

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