Study of Patupilone in Patients With Brain Metastasis From Non-small Cell Lung Cancer

Study summary

The study objective is to evaluate the safety and efficacy of patupilone with respect to early progression and response of patients with non-small cell lung cancer (NSCLC) metastatic to the brain, who have progressed after chemotherapy, surgery and/or radiation.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPatupilone

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 21, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: Patupilone

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Chemotherapy→Surgery→

Study topics

Brain metastases→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

World Health Organization (WHO) performance status of 0, 1 or 2 (corresponding to Karnofsky performance status of 50 or better)
Patients with radiologically proven (by gadolinium-enhanced \[Gd-\] magnetic resonance imaging \[MRI\]) parenchymal brain metastases from histologically confirmed non-small cell lung cancer (the primary disease may be quiescent). Gd-MRI must be performed within 2 weeks of study entry.
Patients should have at least one bidimensionally measurable intracranial lesion of a minimum of 2 cm as defined by Gd-MRI. If the patient has had previous radiation to the marker lesion(s), there must be evidence of residual disease \> 2 cm or the lesion must have demonstrated progression since the radiation.
Those patients progressing on radiotherapy must have a 25% increase in the size of the previously radiated intracranial lesion based on the Neuro-Oncology Criteria of Tumor Response for Central Nervous System (CNS) Tumors or appearance of new lesions.
Patients must be controlled on medication and neurologically stable: stable on steroids and anticonvulsants for at least 2 weeks prior to obtaining the baseline Gd-MRI of the brain, and/or at least 2 weeks prior to beginning study treatment.
Female patients must have a negative serum pregnancy test at screening. (Not applicable to patients with bilateral oophorectomy and/or hysterectomy or to those patients who are postmenopausal.)
All patients of reproductive potential must agree to use an effective method of contraception during the study and for three months following termination of treatment.
Written informed consent must be obtained.

Reasons someone may not be able to joinExclusion criteria

Clinical evidence of leptomeningeal disease
Patients with extracranial disease in more than 3 organ sites including the primary tumor.
Patients who have received any investigational compound within the past 28 days or who are planning to receive other investigational drugs while participating in the study
Prior administration of epothilone(s)
Patients with peripheral neuropathy \> grade 1
Patients with unresolved diarrhea within the last 7 days before treatment.
Patients receiving known diarrheogenic agents must stop treatment with these agents prior to enrollment in the study.
Radiotherapy \< 3 weeks prior to study entry
Prior intracranial surgery \< 3 weeks prior to study entry; patient must have recovered from surgery prior to study entry.
Chemotherapy \< 3 weeks prior to study entry; \< 6 weeks from prior nitrosoureas.
Severe cardiac insufficiency (New York Heart Association \[NYHA\] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
Radiotherapy not permitted while on study. Exception: palliative radiotherapy of metastasis in extremities is allowed, but such lesions cannot be used as target or non-target lesions.
Patients receiving hematopoietic growth factors except for erythropoietin
Patients taking Coumadin® or other agents containing warfarin, with the exception of low dose Coumadin® (1 mg or less daily) administered prophylactically for maintenance of in-dwelling lines or ports

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California Davis Cancer Center UC Davis Cancer (3)Sacramento, California
Dana Farber Cancer Institute SCBoston, Massachusetts
Wayne State University/Wertz Clinical Cancer Center Div. of Hematology/OncologyDetroit, Michigan
St Louis University Cancer CenterSt Louis, Missouri
Washington University School of Medicine-Siteman Cancer CtrSt Louis, Missouri
Dartmouth Hitchcock Medical Center OncologyLebanon, New Hampshire
Roswell Park Cancer InstituteBuffalo, New York
Memorial Sloan Kettering Cancer CenterNew York, New York
Columbia University Medical Center New York PresbyterianNew York, New York
Duke University Medical Center Dept. of DUMC (3)Durham, North Carolina
Cleveland Clinic FoundationCleveland, Ohio
University of Wisconsin Hospital and ClinicsMadison, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 21, 2021. Always confirm current availability with the study team.

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