First in Patient Study for PF-06840003 in Malignant Gliomas
NCT ID: NCT02764151
Last Updated: 2020-01-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
17 participants
INTERVENTIONAL
2016-09-09
2018-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PF-06840003
Daily Oral PF-06840003
PF-06840003
Daily Oral PF-06840003
Interventions
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PF-06840003
Daily Oral PF-06840003
Eligibility Criteria
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Inclusion Criteria
* For patients with Grade IV GBM, recurrent disease at the time of the first or second recurrence or progression. For patients with Grade III anaplastic gliomas, recurrent disease at the time of at least a first recurrence but no more than a fourth recurrence or progression
* Karnofsky performance score greater than or equal to 70%
* Adequate bone marrow, kidney and liver function
Exclusion Criteria
* Previous anti-angiogenics or anti-vascular endothelial growth factor within 12 months of registration
* Requires treatment with high dose systemic corticosteroids defined as \>2 mg/day
* Radiation therapy within 12 weeks of registration
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Clinical & Translational Research Center
Los Angeles, California, United States
UCLA Oncology Center
Los Angeles, California, United States
UCLA School of Medicine
Los Angeles, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
Columbia University Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
CUMC Research Pharmacy
New York, New York, United States
Columbia Doctors Tarrytown
Tarrytown, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Duke University Medical Center, Duke Cancer Center
Durham, North Carolina, United States
Countries
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References
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Reardon DA, Desjardins A, Rixe O, Cloughesy T, Alekar S, Williams JH, Li R, Taylor CT, Lassman AB. A phase 1 study of PF-06840003, an oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor in patients with recurrent malignant glioma. Invest New Drugs. 2020 Dec;38(6):1784-1795. doi: 10.1007/s10637-020-00950-1. Epub 2020 May 20.
Gomes B, Driessens G, Bartlett D, Cai D, Cauwenberghs S, Crosignani S, Dalvie D, Denies S, Dillon CP, Fantin VR, Guo J, Letellier MC, Li W, Maegley K, Marillier R, Miller N, Pirson R, Rabolli V, Ray C, Streiner N, Torti VR, Tsaparikos K, Van den Eynde BJ, Wythes M, Yao LC, Zheng X, Tumang J, Kraus M. Characterization of the Selective Indoleamine 2,3-Dioxygenase-1 (IDO1) Catalytic Inhibitor EOS200271/PF-06840003 Supports IDO1 as a Critical Resistance Mechanism to PD-(L)1 Blockade Therapy. Mol Cancer Ther. 2018 Dec;17(12):2530-2542. doi: 10.1158/1535-7163.MCT-17-1104. Epub 2018 Sep 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C0591001
Identifier Type: -
Identifier Source: org_study_id
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