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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457119
• Other study ID #: CRAD001C2114
• Secondary ID: 2006-002760-26
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2007
• Last updated: February 9, 2013
• Start date: February 2007
• Est. completion date: November 2009

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: National Health and Medical Research CouncilGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 23 Years to 76 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Heidelberg	Victoria
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Heidelberg
United States	U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office	Dallas	Texas
United States	MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.	Houston	Texas
United States	LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center	New Orleans	Louisiana
United States	Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the feasible doses/regimens of RAD001 in combination with chemotherapy. Primary endpoint is the End-of-cycle DLT rate		Ever 3 months or once a critical DLT occurs	Yes
Secondary	Relative dose intensity (RDI) of Carboplatin + Paclitaxel (step 1)		End of step 1	Yes
Secondary	Relative dose intensity (RDI) of Carboplatin + Paclitaxel + bevacizumab (step 2)		End of Step 2	Yes
Secondary	PK parameters derived from PK profiles of treatment drugs alone and in combination		End of Step 1 and Step 2	No
Secondary	Best overall response - measured by CT/MRI scan every 6-8 week		Every 6-8 week	No