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

Novartis

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: RAD001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457119

CRAD001C2114

2006-002760-26 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 69 patients

Sex: All

Ages: 23 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 4 patient groups

Step 1 Arm 1

Experimental group

Description:

5mg/day RAD001 + Carboplatin + Paclitaxel

Treatment:

Drug: RAD001

Step 1, Arm 2

Experimental group

Description:

30mg/week RAD001 + Carboplatin + Paclitaxel

Treatment:

Drug: RAD001

Step 2, Arm 1

Experimental group

Description:

5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Treatment:

Drug: RAD001

Step 2, Arm 2

Experimental group

Description:

30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab

Treatment:

Drug: RAD001