scholarly journals Open-Label, Dose-Escalation, Phase 1 Study of Safety and Single and Multiple-Dose Pharmacokinetics of Dichlorphenamide in Healthy Volunteers

2018 ◽  
Vol 8 (1) ◽  
pp. 87-94
Author(s):  
Fredric Cohen
Keyword(s):  
Healthy Volunteers ◽  
Dose Escalation ◽  
Multiple Dose ◽  
Phase 1 ◽  
Open Label ◽  
Phase 1 Study ◽  
Label Dose ◽  
Multiple Dose Pharmacokinetics

Open-label, dose-escalation, phase 1 study of venetoclax in combination with navitoclax and chemotherapy in patients with relapsed acute lymphoblastic leukemia.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. TPS10575-TPS10575 ◽  
Author(s):  
Thomas Alexander ◽  
Seong Lin Khaw ◽  
Jeffrey E. Rubnitz ◽  
Susan I. Vear ◽  
Norman James Lacayo ◽  
...  
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Dose Escalation ◽  
Lymphoblastic Leukemia ◽  
Phase 1 ◽  
Open Label ◽  
Phase 1 Study ◽  
Label Dose

An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study

2019 ◽  
Vol 6 (4) ◽  
pp. e194-e203 ◽  
Author(s):  
Michael R Savona ◽  
Olatoyosi Odenike ◽  
Philip C Amrein ◽  
David P Steensma ◽  
Amy E DeZern ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Myelodysplastic Syndromes ◽  
Phase 1 ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Open Label ◽  
Phase 1 Study ◽  
Label Dose ◽  
Dose Combination

Safety and activity of RRx-001 in patients with advanced cancer: a first-in-human, open-label, dose-escalation phase 1 study

2015 ◽  
Vol 16 (9) ◽  
pp. 1133-1142 ◽  
Author(s):  
Tony Reid ◽  
Bryan Oronsky ◽  
Jan Scicinski ◽  
Curt L Scribner ◽  
Susan J Knox ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Dose Escalation ◽  
Phase 1 ◽  
Open Label ◽  
Phase 1 Study ◽  
Label Dose

scholarly journals A first-in-human, phase 1 study of the NEDD8 activating enzyme E1 inhibitor TAS4464 in patients with advanced solid tumors

2021 ◽  
Author(s):  
Noboru Yamamoto ◽  
Toshio Shimizu ◽  
Kan Yonemori ◽  
Shigehisa Kitano ◽  
Shunsuke Kondo ◽  
...  
Keyword(s):  
Liver Function ◽  
Solid Tumors ◽  
Dose Escalation ◽  
Enzyme Inhibitor ◽  
Phase 1 ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Open Label ◽  
Phase 1 Study ◽  
Open Label Phase

SummaryBackground This open-label, phase 1 study investigated TAS4464, a potent NEDD8-activating enzyme inhibitor, in patients with advanced/metastatic solid tumors (JapicCTI-173,488; registered 13/01/2017). The primary objective was dose-limiting toxicities (DLTs). Maximum-tolerated dose (MTD) was investigated using an accelerated titration design. Methods The starting 10-mg/m2 dose was followed by an initial accelerated stage (weekly dosing; n = 11). Based on liver function test (LFT) results, a 14-day, 20-mg/m2 dose lead-in period was implemented (weekly dosing with lead-in; n = 6). Results Abnormal LFT changes and gastrointestinal effects were the most common treatment-related adverse events (AEs). DLTs with 56-mg/m2 weekly dosing occurred in 1/5 patients; five patients had grade ≥ 2 abnormal LFT changes at 40- and 56-mg/m2 weekly doses. Further dose escalation ceased because of the possibility of severe abnormal LFT changes occurring. DLTs with weekly dosing with lead-in occurred in 1/5 patients at a 56-mg/m2 dose; MTD could not be determined because discontinuation criteria for additional enrollment at that particular dose level were met. As no further enrollment at lower doses occurred, dose escalation assessment was discontinued. Serious treatment-related AEs, AEs leading to treatment discontinuation, and DLTs were all related to abnormal LFT changes, suggesting that TAS4464 administration could affect liver function. This effect was dose-dependent but considered reversible. Complete or partial responses to TAS4464 were not observed; one patient achieved prolonged stable disease. Conclusions MTD could not be determined due to TAS4464 effects on liver function. Further evaluation of the mechanism of NEDD8-activating enzyme inhibitor-induced abnormal liver function is required. Trial registration number JapicCTI-173,488 (registered with Japan Pharmaceutical Information Center). Registration date 13 January 2017

scholarly journals A phase 1/2, open‐label, dose‐escalation study of midostaurin in children with relapsed or refractory acute leukaemia

2018 ◽  
Vol 185 (3) ◽  
pp. 623-627 ◽  
Author(s):  
C. Michel Zwaan ◽  
Stefan Söderhäll ◽  
Benoit Brethon ◽  
Matteo Luciani ◽  
Carmelo Rizzari ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Acute Leukaemia ◽  
Phase 1 ◽  
Open Label ◽  
Dose Escalation Study ◽  
Label Dose

Phase 1, open-label, dose-escalation study of sorafenib in combination with eribulin in patients with advanced, metastatic, or refractory solid tumors

2018 ◽  
Vol 81 (4) ◽  
pp. 727-737 ◽  
Author(s):  
Frederik Marmé ◽  
Carlos Gomez-Roca ◽  
Kristina Graudenz ◽  
Funan Huang ◽  
John Lettieri ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Dose Escalation ◽  
Phase 1 ◽  
Open Label ◽  
Dose Escalation Study ◽  
Label Dose
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