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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Small-Cell Lung Cancer

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 21

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2116

NCT ID:

NCT00466466

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Small-cell Lung Cancer
  • Small-Cell Lung Cancer
  • SCLC
  • Advanced Lung Cancer
  • RAD
  • RAD001
  • Chemotherapy
  • Cisplatin
  • Etoposide
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location
MD Anderson Cancer Center Houston, Texas  77030-4096
Highlands Oncology Group Springdale, Arkansas  72764
University of Colorado Health Sciences Center Denver, Colorado  80262
Dana Faber Cancer Institute Boston, Massachusetts  02115
Cancer Therapy and Research Center at UTHSCSA San Antonio, Texas  78229