A Combined Phase 1 and 2 Study Investigating the Combination of RAD001 and Erlotinib in Patients With Advanced NSCLC Previously Treated Only With Chemotherapy

Novartis Pharmaceuticals1 site in 1 country248 target enrollmentJune 2005

ConditionsNon Small Cell Lung Cancer

InterventionsRAD001 erlotinib

DrugsRAD001 erlotinib

Overview

Phase: Phase 1
Intervention: RAD001
Conditions: Non Small Cell Lung Cancer
Sponsor: Novartis Pharmaceuticals
Enrollment: 248
Locations: 1
Primary Endpoint: Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to assess the value of combined treatment with RAD001 and erlotinib in patients with advanced Non Small Cell Lung Cancer treated only with chemotherapy as systemic therapy.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

March 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

RAD 5mg/day + erlotinib

Intervention: RAD001

erlotinib 150mg/day

Intervention: RAD001

erlotinib 150mg/day

Intervention: erlotinib

Outcomes

Primary Outcomes

Phase 1: Dose limiting toxicities (DLT) and PK drug-drug interaction (DDI) measured during first 28 days of combined treatment for each treatment regimen and dose.

Time Frame: first 28 days of combined treatment

Phase 2: Tumor response assessed by CT scans measured at baseline and after 8 weeks of treatment for each feasible dose/regimen determined in phase 1

Time Frame: at baseline and after 8 weeks of treatment

Secondary Outcomes

Phase 1 and 2: Exploratory Biomarker assessment from archival tumor tissue(Dec 2009)
Phase 1: Tumor response assessed by CT scans measured at baseline, monthly until month 4 then q2months until progression(at baseline, monthly until month 4 then q2months until progression)
Phase 2: Safety and steady state drug levels evaluated monthly(Monthly)