Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02915744 : A Study of Etirinotecan Pegol (NKTR-102) Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Female or male, age ? 18 years.

- Histologically-confirmed carcinoma of the breast (either the primary or metastatic
lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have
either measurable or non-measurable disease according to RECIST version 1.1.

- Patients must have a history of brain metastases that are non-progressing.

- For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen
must have been administered for the indication of metastatic disease.Depending on
receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in
this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted
agents may be required.

- Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic
setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be
omitted if not medically appropriate or contraindicated for the patient).

- Last dose of anticancer therapy must have been administered within 6 months of the
date of randomization into this study.

- All anticancer- and radiation therapy-related toxicities must be completely resolved
or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Demonstrate adequate organ function obtained within 14 days prior to randomization and
analyzed by the central laboratory.

- Women of childbearing potential (WCBP) must agree to use highly effective methods of
birth control throughout the duration of the study until 6 months following the last
dose of study drug.

- Males with female partners of child-bearing potential must agree to use a barrier
contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository)
throughout the duration of the study until 6 months following the last dose of study
drug; in addition to their female partner using either an intrauterine device or
hormonal contraception and continuing until 6 months following the last dose of study
drug. Male patients should not donate sperm until 6 months following the last dose of
study drug.

Exclusion Criteria:

- Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior
to randomization.

- High-dose chemotherapy followed by stem cell transplantation (autologous or
allogeneic).

- Major surgery within 28 days prior to randomization.

- Concomitant use of any anticancer therapy or use of any investigational agent(s).

- Received prior treatment for cancer with a camptothecin-derived agent.

- Lesions on imaging, by cerebrospinal fluid or with neurological findings that are
consistent with leptomeningeal disease or meningeal carcinomatosis.

- Chronic or acute GI disorders resulting in diarrhea of any severity grade.

- Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum
pregnancy test prior to randomization.

- Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.

- Hepatitis B or C, tuberculosis, or HIV.

- Cirrhosis.

- Prior malignancy (other than breast cancer) unless diagnosed and definitively treated
more than 5 years prior to randomization.

- Daily use of oxygen supplementation.

- Significant known cardiovascular impairment.

- Prior treatment with NKTR-102.

- Psychiatric illness, social situation, or geographical situation that preclude
informed consent or limit compliance.

- Known intolerance or hypersensitivity to any of the products used in this study or
their excipients.

- For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not
receive yellow fever vaccine in the 28 days prior to randomization.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02915744      |      Link to official Clinicaltrials.gov listing
Locations
Nedlands,
Australia

Facility: Investigator Site - Nedlands
Investigator:
Contact:
Email not avaialable

Albury, New South Wales
Australia

Facility: Investigatory Site - Albury
Investigator:
Contact:
Email not avaialable

Darlinghurst, New South Wales
Australia

Facility: Investigator Site - Darlinghurst
Investigator:
Contact:
Email not avaialable

Wollongong, New South Wales
Australia

Facility: Investigator Site - Wollongong
Investigator:
Contact:
Email not avaialable

Brisbane, Queensland
Australia

Facility: Investigator Site - Brisbane
Investigator:
Contact:
Email not avaialable

Subiaco, Western Australia
Australia

Facility: Investigator Site - Subiaco
Investigator:
Contact:
Email not avaialable

Brussels,
Belgium

Facility: Investigator Site - Brussels
Investigator:
Contact:
Email not avaialable

Brussels,
Belgium

Facility: Investigator Site - Brussels
Investigator:
Contact:
Email not avaialable

Brussels,
Belgium

Facility: Investigator Site - Brussels
Investigator:
Contact:
Email not avaialable

Charleroi,
Belgium

Facility: Investigator Site - Charleroi
Investigator:
Contact:
Email not avaialable

Edegem,
Belgium

Facility: Investigator Site - Edegem
Investigator:
Contact:
Email not avaialable

Liège,
Belgium

Facility: Investigator Site - Liege
Investigator:
Contact:
Email not avaialable

Namur,
Belgium

Facility: Investigator Site - Namur
Investigator:
Contact:
Email not avaialable

Sint-Niklaas,
Belgium

Facility: Investigator Site - Sint-Niklaas
Investigator:
Contact:
Email not avaialable

Montréal, Quebec
Canada

Facility: Investigator Site - Montreal
Investigator:
Contact:
Email not avaialable

Praha,
Czechia

Facility: Investigator Site - Praha
Investigator:
Contact:
Email not avaialable

Grenoble,
France

Facility: Investigator Site - Grenoble
Investigator:
Contact:
Email not avaialable

Le Mans,
France

Facility: Investigator Site - Le Mans
Investigator:
Contact:
Email not avaialable

Nîmes,
France

Facility: Investigator Site - Nimes
Investigator:
Contact:
Email not avaialable

Paris,
France

Facility: Investigator Site - Paris
Investigator:
Contact:
Email not avaialable

Rennes,
France

Facility: Investigator Site - Rennes
Investigator:
Contact:
Email not avaialable

Rouen,
France

Facility: Investigator Site - Rouen
Investigator:
Contact:
Email not avaialable

Saint-Cloud,
France

Facility: Investigator Site - Saint-Cloud
Investigator:
Contact:
Email not avaialable

Strasbourg,
France

Facility: Investigator Site - Strasbourg
Investigator:
Contact:
Email not avaialable

Toulouse,
France

Facility: Investigator Site - Toulouse
Investigator:
Contact:
Email not avaialable

Be'er Ya'aqov,
Israel

Facility: Investigator Site - Be'er Ya'aqov
Investigator:
Contact:
Email not avaialable

Beersheba,
Israel

Facility: Investigator Site - Beersheba
Investigator:
Contact:
Email not avaialable

Haifa,
Israel

Facility: Investigator Site - Haifa
Investigator:
Contact:
Email not avaialable

Jerusalem,
Israel

Facility: Investigator Site - Jerusalem
Investigator:
Contact:
Email not avaialable

Tel Aviv,
Israel

Facility: Investigator Site - Tel Aviv
Investigator:
Contact:
Email not avaialable

Milan,
Italy

Facility: Investigator Site - Milan
Investigator:
Contact:
Email not avaialable

Napoli,
Italy

Facility: Investigator Site - Napoli
Investigator:
Contact:
Email not avaialable

Christchurch,
New Zealand

Facility: Investigator Site - Christchurch
Investigator:
Contact:
Email not avaialable

Porto,
Portugal

Facility: Investigator Site - Porto
Investigator:
Contact:
Email not avaialable

Barcelona,
Spain

Facility: Investigator Site - Barcelona
Investigator:
Contact:
Email not avaialable

Barcelona,
Spain

Facility: Investigator Site - Barcelona
Investigator:
Contact:
Email not avaialable

Granollers,
Spain

Facility: Investigator Site - Granollers
Investigator:
Contact:
Email not avaialable

Jaén,
Spain

Facility: Investigator Site - Jaen
Investigator:
Contact:
Email not avaialable

Madrid,
Spain

Facility: Investigator Site - Madrid
Investigator:
Contact:
Email not avaialable

Madrid,
Spain

Facility: Investigator Site - Madrid
Investigator:
Contact:
Email not avaialable

Santa Cruz de Tenerife,
Spain

Facility: Investigator Site - Santa Cruz de Tenerife
Investigator:
Contact:
Email not avaialable

Sevilla,
Spain

Facility: Investigator Site - Sevilla
Investigator:
Contact:
Email not avaialable

Sevilla,
Spain

Facility: Investigator Site - Sevilla
Investigator:
Contact:
Email not avaialable

San Sebastián, Gipuzkoa
Spain

Facility: Investigator Site - San Sebastián
Investigator:
Contact:
Email not avaialable

Bradford,
United Kingdom

Facility: Investigator Site - Bradford
Investigator:
Contact:
Email not avaialable

Manchester,
United Kingdom

Facility: Investigator Site - Manchester
Investigator:
Contact:
Email not avaialable

Nottingham,
United Kingdom

Facility: Investigator Site - Nottingham
Investigator:
Contact:
Email not avaialable

Tucson, Arizona
Facility: Investigator Site - Tucson
Investigator:
Contact:
Email not avaialable

Orange, California
Facility: Investigator Site - Orange
Investigator:
Contact:
Email not avaialable

San Francisco, California
Facility: Investigator Site - San Francisco
Investigator:
Contact:
Email not avaialable

Miami, Florida
Facility: Investigator Site - Miami
Investigator:
Contact:
Email not avaialable

West Palm Beach, Florida
Facility: Investigator Site - West Palm Beach
Investigator:
Contact:
Email not avaialable

Athens, Georgia
Facility: Investigator Site - Athens
Investigator:
Contact:
Email not avaialable

Baltimore, Maryland
Facility: Investigator Site - Baltimore
Investigator:
Contact:
Email not avaialable

Boston, Massachusetts
Facility: Investigator Site - Boston
Investigator:
Contact:
Email not avaialable

Minneapolis, Minnesota
Facility: Investigator Site - Minneapolis
Investigator:
Contact:
Email not avaialable

Saint Louis, Missouri
Facility: Investigator Site - Saint Louis
Investigator:
Contact:
Email not avaialable

New York, New York
Facility: Investigator Site - New York
Investigator:
Contact:
Email not avaialable

Chapel Hill, North Carolina
Facility: Investigator Site - Chapel Hill
Investigator:
Contact:
Email not avaialable

Columbus, Ohio
Facility: Investigator Site - Columbus
Investigator:
Contact:
Email not avaialable

Germantown, Tennessee
Facility: Investigator Site - Germantown
Investigator:
Contact:
Email not avaialable

Nashville, Tennessee
Facility: Investigator Site - Nashville
Investigator:
Contact:
Email not avaialable

Fort Worth, Texas
Facility: Investigator Site - Fort Worth
Investigator:
Contact:
Email not avaialable

Houston, Texas
Facility: Investigator Site - Houston
Investigator:
Contact:
Email not avaialable

Salt Lake City, Utah
Facility: Investigator Site - Salt Lake City
Investigator:
Contact:
Email not avaialable

Seattle, Washington
Facility: Investigator Site - Seattle
Investigator:
Contact:
Email not avaialable




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