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

Part of paid clinical trials in Stanford, California.

Sponsor
Joel Neal
Study ID
NCT02312622
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2015
Status verified
Nov 2023
Primary completion
Sep 8, 2018
Completion
Jul 31, 2019

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - Pegylated Irinotecan to treat NSCLC
    Patients with non-small cell lung carinoma (NSCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort B - Pegylated Irinotecan to treat SCLC
    Patients with small cell lung carinoma (SCLC) will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Cohort C - Pegylated Irinotecan to treat mBC
    Patients with metastatic breast cancer (MBC) to brain will receive pegylated irinotecan intravenously (IV) over 90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Central Nervous System (CNS) Disease Control Rate (Cohort A and C) [ Time Frame: At 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University, School of MedicineStanfordCalifornia94305-

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By research site
Stanford University, School of Medicine· Stanford, CA

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