NCT00466466

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Last Updated

December 21, 2020

Status Verified

November 1, 2011

Enrollment Period

3.6 years

First QC Date

April 26, 2007

Last Update Submit

December 17, 2020

Conditions

Small-Cell Lung Cancer

Keywords

Small-Cell Lung CancerSCLCAdvanced Lung CancerRADRAD001ChemotherapyCisplatinEtoposide

Outcome Measures

Primary Outcomes (1)

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

    Day 21

Secondary Outcomes (3)

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

    within 6 cycles (Day 126)

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

    During the first 6 cycles

  • Overall tumor response

    Every 6-8 weeks

Study Arms (2)

Daily dosing RAD001

EXPERIMENTAL
Drug: Everolimus

Weekly dosing RAD001

EXPERIMENTAL
Drug: Everolimus

Interventions

EverolimusDRUG

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.

Also known as: RAD001
Daily dosing RAD001Weekly dosing RAD001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Dana Faber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

Novartis Investigative Site

Paris, France

Location

Related Links

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 27, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2010

Last Updated

December 21, 2020

Record last verified: 2011-11

Locations

FR(1)US(5)