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Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02796261
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : March 15, 2019
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.

Brief Summary:
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma Drug: Eflornithine Drug: Lomustine Phase 3

Detailed Description:

This study will consist of 4 study periods of up to 50 months in total, consisting of:

Screening Period - A maximum screening duration of 4 weeks.

Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period - Up to 24 months.

A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Study Start Date : July 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Drug: Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Other Name: DFMO

Drug: Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU
  • Gleostine

Active Comparator: Lomustine
Lomustine dosed every 6 weeks
Drug: Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU
  • Gleostine

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 4 years ]
  2. Objective response rate (ORR) [ Time Frame: 4 years ]

Other Outcome Measures:
  1. Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria [ Time Frame: 4 years ]
  2. OS rate at 18 months (OS-18) [ Time Frame: 18 months ]
  3. Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples [ Time Frame: 4 years ]
  4. Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
  5. PK - Area under the curve (AUC) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

  • Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
  • First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:

    1. Gd-contrast lesion margins are not clearly defined,
    2. Gd-contrast lesions are only measurable in one dimension,
    3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,
    4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
    5. Recent histopathological confirmation of WHO grade 3 AA
  • Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
  • Completion of EBRT ≥ 6 months prior to randomization.
  • A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
  • Karnofsky Performance Status (KPS) score of ≥ 70.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not eligible for study participation:

  • MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
  • Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
  • Prior systemic therapy for recurrence of AA.
  • Presence of extracranial or leptomeningeal disease.
  • Prior lomustine use.
  • Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  • Pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02796261

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Contact: Marietta Franco, MS 6504506634
Contact: Kathleen Villamejor, BS 6506569424

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35401
Contact: Burt Nabors, MD    205-934-1813   
Contact: Thiru Pillay    1 (205) 934-1432   
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Surasak Phuphanich, MD    602-406-6262   
Contact: Terry Thomas    602-406-7709   
United States, California
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Contact: Richard Green, MD    323-783-4200   
Contact: Sandra Baker    1 (310) 517-3896   
University of Southern California Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Naveed Wagle, MD    323-865-3977   
Contact: Aida Lozada    1 (323) 865-3980   
University of California Los Angeles - Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Timothy Cloughesy, MD    310-825-5321   
Contact: Emese Filka    1 (310) 794-3521   
Hoag Memorial Hospital Presbyterian Not yet recruiting
Newport Beach, California, United States, 92658
Contact: Jose Carrillo, MD    949-764-4430      
Hoag Memorial Hospital Presbyterian Not yet recruiting
Newport Beach, California, United States, 92663
Contact: Jose Carrillo, MD    310-829-8265   
University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Daniela Bota, MD    714-456-7032   
Contact: Jennifer Scott    714-509-2370   
Kaiser Permanente Center Recruiting
Redwood City, California, United States, 94063
Contact: Piia Thomas, MD    650-299-3690   
Contact: Nancy Mendelssohn    650-299-4165   
Kaiser Permanente Recruiting
Sacramento, California, United States, 95825
Contact: Enrico Lallana, MD    916-973-5490   
Contact: Renee Cunanan    1 (916) 973-4885   
UCSD Moores Cancer Center Recruiting
San Diego, California, United States, 92093
Contact: David Piccioni, MD    858-822-7778   
Contact: Jennifer Moral    858-822-5377   
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Nicholas Butowski, MD    415-353-7500   
Contact: Eduardo Rodriguez Almaraz    (415) 514-5529   
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Santosh Kesari, MD    858-822-7524   
Contact: Naj Boucher    (310) 582-7460    Najee.Boucher@Providence.Org   
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Douglas Ney, MD    303-724-2184   
Contact: Rachel Freedman    720-848-0734   
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Michael Pearlman, MD    303-781-4485   
Contact: Judith Stucky    303-806-7416   
United States, Florida
Boca Raton Regional Hospital, Eugene M. & Christine E. Lynn Cancer Institute Withdrawn
Boca Raton, Florida, United States, 33486
The University of Florida Health System - UF Health Neurosurgery Withdrawn
Gainesville, Florida, United States, 32610
Mayo Clinic - Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven Rosenfeld, MD    904-953-2000   
Contact: Patricia Shwarts    904-953-8817   
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Peter Forsyth, MD    813-745-4673   
Contact: Melissa Wicklund    813-745-3620   
United States, Georgia
Piedmont Physicians Neuro-Oncology Recruiting
Atlanta, Georgia, United States, 30309
Contact: Erin Dunbar, MD    404-605-2050   
Contact: Ali Arabnia    404-425-7943   
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Alfredo Voloschin, MD    404-778-1900   
Contact: Rikesh Patel    404-778-2981   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Priya Kumthekar, MD    312-503-1818   
Contact: Jade Lieu    312-695-9157   
Advocate Lutheran General Hospital Withdrawn
Park Ridge, Illinois, United States, 60068
Northwestern Medicine CDH Cancer Center Recruiting
Warrenville, Illinois, United States, 60055
Contact: Sean Grimm, MD    630-352-5450   
Contact: Edith Maritato    630-352-5362   
United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Varun Monga, MD    319-353-8775   
Contact: Karen Parrott    1 (319) 353-6347   
United States, Kentucky
University of Kentucky Chandler Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Villano, MD    859-257-3379   
Contact: Elizabeth Rush    859-218-6147   
Norton Cancer Institute - Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Renato LaRocca, MD    502-561-8200   
Contact: Lisa Bailey    1 (502) 629-3449   
United States, Louisiana
Louisiana State University Health Sciences Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Aaron Mammoser, MD    504-568-2698   
Contact: Melissa Ensminger    504-568-2507   
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders Recruiting
Scarborough, Maine, United States, 04074
Contact: Devon Evans, MD    207-396-7600   
Contact: Linda Reinholdtsen    207-396-7791   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Tracy Batchelor, MD    617-724-8770   
Contact: Arielle Spivey    617-724-2192   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Eric Wong, MD    617-667-1665   
Contact: Alexandra Calafiore    617-975-7458   
Dana Farber Cancer Institute, Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick Wen, MD    617-632-2166   
Contact: Gina Cach    (617) 632-6668    Gina_Cach@DFCI.HARVARD.EDU   
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Yoshie Umemura, MD    734-232-9039   
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Tobias Walbert, MD    313-916-2723   
Contact: John Gaggin    313-916-3731   
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sani Kizilbash, MD    507-293-0494   
Contact: Cole McKean    507-293-3864   
United States, Missouri
Saint Luke's Cancer Institute Not yet recruiting
Kansas City, Missouri, United States, 64111
Contact: Scott Turner, MD    816-932-2700   
Contact: Tina Bradley    816-932-2677   
HCA Midwest Division Recruiting
Kansas City, Missouri, United States, 64132
Contact: Amandeep Kalra, MD    816-698-7000   
Contact: Pamela McCann    1 (816) 2763890   
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Milan Chheda, MD    314-362-2877   
Contact: Grayson Talcott    314-273-0656   
United States, New Jersey
JFK Medical Center Recruiting
Edison, New Jersey, United States, 08820
Contact: Joseph Landolfi, MD    732-321-7010   
Contact: Elizabeth Murray    732-321-7000 ext 61689   
United States, New York
Dent Neurologic Institute Withdrawn
Buffalo, New York, United States, 14226
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Lyndon Kim, MD    212-824-8579   
Columbia University Medical Center, The Neurological Institute Recruiting
New York, New York, United States, 10032
Contact: Teri Kreisl, MD    212-342-0571   
Contact: David Cieremans    (212) 342-4743   
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Simon Khagi, MD    919-966-4786   
Contact: Correai Moore    919-966-4432   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Annick Desjardins, MD    919-668-2993   
Contact: Edy Parker    (919) 681-9932   
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Roy Strowd, MD    336-713-6979   
Contact: Ashley Carroll    336-713-3539   
United States, Ohio
The Cleveland Clinic, Richard E. Jacobs Health Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: David Peereboom, MD    216-445-6068   
Contact: Cathy Brewer    216-444-7937   
OhioHealth Research and Innovation Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Mohamed Hamza, MD    614-566-4200   
Contact: Kevin Miller    614-788-3886   
United States, Oregon
Providence Brain & Spine Institute Recruiting
Portland, Oregon, United States, 97225
Contact: Ricky Chen, MD    503-216-6300   
Contact: Kyla Lindberg    503-216-1191   
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Withdrawn
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Arati Desai, MD    215-662-7804   
Contact: Jasmin Hussain    267-449-9992   
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jon Glass, MD    215-955-9797   
Contact: Ginevra Park    215-955-5891   
United States, South Carolina
Medical University of South Carolina, Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Scott Lindhorst, MD    843-792-2568   
Contact: John Keller    843-792-2209   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Paul Moots, MD   
Contact: Katie Lyons    615-936-8606   
United States, Texas
Texas Oncology Austin Brain Tumor Center Recruiting
Austin, Texas, United States, 78705
Contact: Morris Groves, MD    512-421-4100   
Contact: Kristen Brueggemann    1 (512) 427-9400   
Neuro-Oncology Associates Recruiting
Dallas, Texas, United States, 75246
Contact: Karen Fink, MD    214-820-8690   
Contact: Sido Oghenevovwero    214-820-6168   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Rebecca Harrison, MD    832-640-5463   
Contact: Laci Clark    713-794-4476   
Baylor Scott & White Medical Center - Temple Recruiting
Temple, Texas, United States, 76508
Contact: Ekokobe Fonkem, MD    214-724-4179   
Contact: Sanjib Mukherjee    254-724-6183   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Howard Colman, MD    801-581-7200   
Contact: Brett Johnson    1 (801) 587-4429   
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States, 98122
Contact: Tara Benkers, MD    206-320-2300   
Contact: Nathan Hansen    12063866073   
United States, Wisconsin
Waukesha Memorial Hospital Withdrawn
Waukesha, Wisconsin, United States, 53188-5031
Universitair Ziekenhuis Antwerpen Withdrawn
Edegem, Antwerpen, Belgium, 2650
Universitair Ziekenhuis Leuven Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Paul Clement, MD    +3216346900   
Contact: Nancy Beckers    +3216347666   
Cliniques Universitaires UCL De Mont-Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Lionel D'Hondt, MD    +3281423858   
Contact: Frédéric Bellemans    +3281423855   
Onze Lieve Vrouwziekenhuis Aalst Withdrawn
Aalst, Oost-Vlaanderen, Belgium, 9300
Canada, Alberta
Cross Cancer Institute Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Jacob Easaw, MD    780-432-8824   
Contact: Holly Toker    (780)577-8105   
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Gloria Urgoiti, MD    403-521-3912   
Contact: Sonali Deshpande    403-521-3888   
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Marshall Pitz, MD    204-787-8642   
Contact: Caitlin Kitkowski    204-787-4148   
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Garth Nicholas, MD    613-737-7700 ext. 70179   
Contact: Kaitlyn Chambers    613-737-7700 ext. 70955   
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: James Perry, MD    416-480-4766   
Contact: Hyla Okorofsky    416-480-5000 ext. 7362   
Princess Margaret Cancer Center Recruiting
Toronto, Ontario, Canada, M5G2M9
Contact: Warren Mason, MD    416-946-2277   
Contact: Elena Chizhov    416-946-4603   
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montréal, Quebec, Canada, H3A 2B4
Contact: Kevin Petrecca, MD    514-398-2591   
Contact: Adrien Poulin    514-398-2801   
Hôpital Pierre Wertheimer - Hospices Civils de Lyon Not yet recruiting
Bron, France, 69500
Contact: Francois Ducray, MD    +33 4 72 68 13 21   
Centre Jean Perrin Not yet recruiting
Clermont-Ferrand, France, 63011
Contact: Xavier Durando, MD    +33 4 73 27 80 05   
Centre Georges François Leclerc Not yet recruiting
Dijon, France, 21000
Contact: Francois Ghiringhelli, MD    +33 3 80 73 75 00   
Hôpital de la Timone Recruiting
Marseille, France, 13005
Contact: Oliver Chinot, MD    +33 4 91 38 65 69   
Contact: Didier Autran    +33491384834   
Hôpital Universitaire Pitié Salpêtrière Not yet recruiting
Paris, France, 75013
Contact: Marc Sanson, MD    +33 1 42 16 03 91   
Universtaetsklinikum Heidelberg - Neurologische Klinik Withdrawn
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Universtaetsklinikum Erlangen - Neurologische Klinik Withdrawn
Erlangen, Bayern, Germany, 91054
Klinik und Poliklinik fur Neurologie der Universitat Regensburg Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Peter Hau, MD    +4909419418083   
Contact: Heike Weißwange    +4909419418464   
Johnn-Wofgang-Goethe-Universitat Frankfurt Withdrawn
Frankfurt, Hessen, Germany, 60528
Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III Withdrawn
Bonn, Nordrhein-Westfalen, Germany, 53105
Heinrich-Heine-Universitat Duesseldorf Recruiting
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Contact: Michael Sabel, MD    +4902118117937   
Contact: Nicole Dietrichs    +4902118107471   
Universitätsklinikum Essen Recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
Contact: Martin Glas, MD    +492017236513   
Contact: Ina Groen    +49201723650783707   
Universtatsklinikum Koln Klinik und Poliklinik fur Neurologie Withdrawn
Köln, Nordrhein-Westfalen, Germany, 50937
Universitätsklinik Leipzig - Medizinische Klinik und Poliklinik I Klinik für Strahlentherapie Withdrawn
Leipzig, Sachsen, Germany, 04103
Charite Universitätsmedizin Berlin Withdrawn
Berlin, Germany, 10117
Ruhr-Universitaet Bochum - Knappschaftskrankenhaus Bochum-Langendreer - Neurologische Withdrawn
Bochum, Germany
Universitaetsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Manfred Westphal, MD    +49040741053750   
Contact: Monique Beyer    +4940741053750   
Universtaetsklinikum Giessen und Marburg GmbH - Marburg - Neurologische Klinik Withdrawn
Marburg, Germany
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Oncohematology IRST Cesena Withdrawn
Cesena, Italy
Fondazione IRCCS - Instituto Neurologico Carlo Besta Recruiting
Milano, Italy, 20133
Contact: Gaetano Finocchiaro, MD    39 02-2394-2454   
Contact: Paola Porrati    +390223942769   
Istituto Oncologico Veneto Recruiting
Padova, Italy
Contact: Giuseppe Lombardi, MD    +390498215910   
Contact: Miriam Farina    +390498215908   
Istituto Nazionale dei Tumori Regina Elena - IRE Withdrawn
Roma, Italy, 00144
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte Withdrawn
Siena, Italy, 53100
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette Recruiting
Torino, Italy, 10126
Contact: Riccardo Soffietti, MD    +390116334904   
Contact: Giulia Machese    +39 0116334904   
Sint Elisabeth Ziekenhuis Recruiting
Tilburg, Noord-Brabant, Netherlands, 5022 GC
Contact: Laurens Beerepoot, MD    +31135393069   
Contact: Chantal Knapen    +31657341761   
Vrije Universiteit Medisch Centrum (VUMC) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Myra Van Linde, MD    +31204444321   
Contact: Johanna Smit    +31204444354   
Erasmus Medisch Centrum Daniel den Hoed Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3075 EA
Contact: Martin Van den Bent, MD    +31107041415   
Contact: Irene van Heuvel    +31107041744   
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Filip De Vos, MD    +31243610353   
Contact: Anette Van Dijk    +31 88 75 562 63   
United Kingdom
University Hospitals Birmingham NHS Foundation Trust Not yet recruiting
Birmingham, United Kingdom, B15 2TH
Contact: Sara Meade, MD    0121 3713589   
Edinburgh Cancer Centre - Western General Hospital Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
Contact: Sara Erridge, MD    +44( 0)131 537 3266   
Guy's Hospital Not yet recruiting
London, United Kingdom, SE1 9RT
Contact: Lucy Brazil, MD    020 7188 1447   
The Royal Marsden NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Liam Welsh, MD    020 8661 3300   
Sponsors and Collaborators
Orbus Therapeutics, Inc.
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Study Director: Marietta Franco, MS Orbus Therapeutics, Inc.

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Responsible Party: Orbus Therapeutics, Inc. Identifier: NCT02796261     History of Changes
Other Study ID Numbers: OT-15-001
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Orbus Therapeutics, Inc.:
Anaplastic Astrocytoma
Grade 3 Glioma
Brain Cancer
Brain Tumor
Progressive Anaplastic Astrocytoma
Recurrent Anaplastic Astrocytoma
Progressive Glioma
Recurrent Glioma
Malignant Glioma
Progressive Brain Tumor
Recurrent Brain Tumor
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors