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Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

Primary Purpose

Small-Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Everolimus

About this trial

This is an interventional treatment trial for Small-Cell Lung Cancer focused on measuring Small-Cell Lung Cancer, SCLC, Advanced Lung Cancer, RAD, RAD001, Chemotherapy, Cisplatin, Etoposide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
Age ≥ 18 years
WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
Adequate bone marrow, liver and renal function

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
Symptomatic or uncontrolled brain metastases
Other cancers within the past 5 years
Pregnant or breastfeeding women

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

Highlands Oncology Group
University of Colorado Health Sciences Center
Dana Faber Cancer Institute
MD Anderson Cancer Center
Cancer Therapy and Research Center at UTHSCSA
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Daily dosing RAD001

Weekly dosing RAD001

Arm Description

Outcomes

Primary Outcome Measures

Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1

Secondary Outcome Measures

Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen

PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles

Overall tumor response

Full Information

NCT ID

NCT00466466

First Posted

April 26, 2007

Last Updated

December 17, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00466466

Brief Title

Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

Official Title

A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small-Cell Lung Cancer

Keywords

Small-Cell Lung Cancer, SCLC, Advanced Lung Cancer, RAD, RAD001, Chemotherapy, Cisplatin, Etoposide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Daily dosing RAD001

Arm Type

Experimental

Arm Title

Weekly dosing RAD001

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Everolimus

Other Intervention Name(s)

RAD001

Intervention Description

RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.

Primary Outcome Measure Information:

Title

Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1

Time Frame

Day 21

Secondary Outcome Measure Information:

Title

Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen

Time Frame

within 6 cycles (Day 126)

Title

PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles

Time Frame

During the first 6 cycles

Title

Overall tumor response

Time Frame

Every 6-8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC) Age ≥ 18 years WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions) Adequate bone marrow, liver and renal function 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 Symptomatic or uncontrolled brain metastases Other cancers within the past 5 years Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

University of Colorado Health Sciences Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Dana Faber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Cancer Therapy and Research Center at UTHSCSA

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

Paris

Country

France

12. IPD Sharing Statement

Links:

URL

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4726

Description

Results for CRAD001C2116 can be found on the Novartis Clinical Trial Results Website

Learn more about this trial

Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

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