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Open Label, Non-randomized, Phase 2 Study Investigating the Effect of RAD001 Monotherapy in Patients With Advanced NSCLC Previously Treated With Either Chemotherapy Only or With Chemotherapy and EGFR Inhibitor(s)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small-cell Lung Carcinoma

Thank you

Trial Information

Open Label, Non-randomized, Phase 2 Study Investigating the Effect of RAD001 Monotherapy in Patients With Advanced NSCLC Previously Treated With Either Chemotherapy Only or With Chemotherapy and EGFR Inhibitor(s)


Inclusion Criteria:



- Patients with advanced (unresectable or metastatic) NSCLC

- Tissue sample of the metastatic or primary tumor available for pathology evaluation
and molecular marker analyses

- Patients who have received ≤ 2 chemotherapy regimens, one of which must have included
cisplatinum or carboplatin, and who have documented evidence of tumor progression
(Arm 1)

- Patients who have received ≤ 2 chemotherapy regimens, one of which must have included
cisplatinum or carboplatin as well as a small molecule EGFR inhibitor (as a
separate regimen) with documented tumor progression despite at least 4 weeks therapy
with either gefitinib or erlotinib (Arm 2)

Exclusion Criteria:

- Concurrent therapy with agents used otherwise as anticancer therapy (for example,
methotrexate for rheumatoid arthritis)

- Any investigational drug, other than EGFR inhibitor (Arm 2), within the preceding 4
weeks

- Chronic treatment with steroids or another immunosuppressive agent

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical efficacy based on the evaluation of objective tumor response rate (RR)

Outcome Time Frame:

until progressive disease or unacceptable toxicity.

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceutcals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2235

NCT ID:

NCT00124280

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Lung cancer
  • non-small cell
  • everolimus
  • Non-small cell lung cancer (NSCLC)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Nevada Cancer InstituteLas Vegas, Nevada  89135
MD Anderson Cancer Center, Department of Thoracic /Head and Neck Medical OncologyHouston, Texas  77030