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Brief Title: Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer
Official Title: A Phase 2 Study of Etirinotecan Pegol (NKTR-102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)
Study ID: NCT02312622
Brief Summary: This phase 2 trial evaluates how well pegylated irinotecan (NKTR-102) works in treating patients with non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), or breast cancer (mBC) that has spread to the brain and does not respond to treatment. Pegylated irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: Primary Objective: For cohort A and Cohort C, to determine the central nervous system (CNS) disease control rate (number of patients with stable disease or partial response or complete response / total number of treated patients) at 12 weeks following treatment with etirinotecan pegol in patients with advanced non-small cell lung cancer (NSCLC) or with metastatic brain cancer (mBC) with refractory brain metastases Secondary Objectives: Cohorts A and C: * To measure the overall disease control rate and response rate for patients receiving study therapy * To measure the systemic (non-CNS) disease control rate and response rate for patients receiving study therapy * To observe the progression free survival of the study population * To observe the overall survival of the study population Cohort B: • To observe CNS and systemic disease control in small cell lung cancer (SCLC) Cohorts A, B and C: • To determine the safety profile of etirinotecan pegol
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, School of Medicine, Stanford, California, United States
Name: Joel Neal
Affiliation: Stanford University Hospitals and Clinics
Role: PRINCIPAL_INVESTIGATOR