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Study to Evaluate SCH 900105 in Combination With Gefitinib in Subjects With Non-Small Cell Lung Cancer (NSCLC) (Study P06162AM1)

2014-07-23 21:11:16 | BioPortfolio

Summary

During Phase 1b portion, there will be a dose-escalation of SCH 900105 in combination with the recommended dose of gefitinib in subjects with NSCLC or advanced solid tumors. The objective is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended Phase 2 dose (RP2D) in combination with gefitinib for the Phase 2 portion.

The Phase 2 is an open label, 2 arm, randomized study designed to compare the combination of SCH 900105 and gefitinib versus gefitinib alone in clinically selected Asian subjects with previously untreated lung adenocarcinoma who have a high likelihood of harboring activating EGFR mutations. Subjects who progress after initial disease control in the gefitinib alone arm may crossover to the combination arm

Study Design

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

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention

SCH 900105, Gefitinib

Location

Investigational Site 1
Singapore
Singapore

Status

Recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:16-0400

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

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An anaplastic, highly malignant, and usually bronchogenic carcinoma composed of small ovoid cells with scanty neoplasm. It is characterized by a dominant, deeply basophilic nucleus, and absent or indistinct nucleoli. (From Stedman, 25th ed; Holland et al., Cancer Medicine, 3d ed, p1286-7)

A carcinoma discovered by Dr. Margaret R. Lewis of the Wistar Institute in 1951. This tumor originated spontaneously as a carcinoma of the lung of a C57BL mouse. The tumor does not appear to be grossly hemorrhagic and the majority of the tumor tissue is a semifirm homogeneous mass. (From Cancer Chemother Rep 2 1972 Nov;(3)1:325) It is also called 3LL and LLC and is used as a transplantable malignancy.

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