MedTrace Logo

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

NCT02312622 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-12-12

Study results available
· View outcomes & findings →

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.

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

DRUG

Pegylated Irinotecan

Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)

Sponsors & Collaborators

Principal Investigators

  • Joel Neal · Stanford University Hospitals and Clinics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-09-08
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02312622 on ClinicalTrials.gov