drugset / Trial / NCT02764151
First in Patient Study for PF-06840003 in Malignant Gliomas
NaSingle-groupOpen-labelTreatment
Summary
This study will evaluate the safety and tolerability of increasing doses of PF-06840003 in patients with malignant gliomas.
Timeline
- Start
- 2016-09-09
- Primary completion
- 2018-12-26
- Completion
- 2018-12-26
Outcome
Outcome not reported
Stopped: “Sponsor decided to prematurely terminate the study and not to pursue marketing approval for the indication of malignant glioma.”
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PF-06840003 | Small molecule | 125 mg | Oral |
| Subject | PF-06840003 | Small molecule | 250 mg | Oral |
| Subject | PF-06840003 | Small molecule | 500 mg | Oral |