Completed Clinical Trials

A Study in Non Small Cell Lung Cancer

By April 24, 2017 No Comments

Condition

Non Small Cell Lung Cancer

Estimated Enrollment: 63

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment

Study ID Numbers: 13797|I2I-MC-JMMG

Study First Received: June 1, 2010

Last Updated: September 5, 2014

Estimated Primary Completion Date: May 2013

 

Primary Outcome Measures:

Phase 2: Progression Free Survival Time|Phase 1: Recommended Phase 2 Dose of LY2603618|Phase 2: Overall Survival|Phase 2: Overall Tumor Response Rate: Percentage of Participants who Achieved a Confirmed Best Response of Completed Response (CR) or Partial Response (PR)|Phase 2: Change in Tumor Size|Phase 1: Pharmacokinetic: Maximum Concentration (Cmax) (Pemetrexed, Cisplatin and LY2603618)|Phase 1: Pharmacokinetic: Area Under the Curve (AUC) (Pemetrexed,Cisplatin and LY2603618)|Phase 2: Pharmacokinetic: Maximum Concentration (Cmax) (LY2603618)|Phase2: Pharmacokinetic: Area Under the Curve (AUC) (LY2603618)|Phase 2: Change from Baseline to Long Term Follow-Up in Lung Cancer Symptom Scale (LCSS)|Phase 1: Document any antitumor activity per radiological scans and/or tumor markers|Phase 2: Proportion of Participants Receiving Maintenance Therapy|Phase 2: Clinical Benefit Rate: Percentage of Participant who Achieved a Response of Stable Disease (SD), Partial Response (PR) or Complete Response (CR)

Sponsors and Collaborators:

Eli Lilly and Company

Website Link: https://ClinicalTrials.gov/show/NCT01139775

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