NCT02312622

Phase 2 Etirinotecan Pegol in Refractory Brain Metastases & Advanced Lung Cancer / Metastatic Breast Cancer

A Phase 2 Study of Etirinotecan Pegol (NKTR-102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Joel Neal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stage IV Non-small Cell Lung Cancer (NSCLC)
• Recurrent Non-small Cell Lung Cancer (NSCLC)
• Extensive-stage Small Cell Lung Cancer (SCLC)
• Recurrent Small Cell Lung Cancer (SCLC)
• Tumors Metastatic to Brain
• Metastatic Breast Cancer (mBC)

Interventions

Type	Name	Description
DRUG	Pegylated Irinotecan	Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-09-08
• Completion: 2019-07-01
• First posted: 2014-12-09
• Last updated: 2023-12-12
• Results posted: 2019-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study