Evaluation of the safety of C-1311 (SYMADEX) administered in a phase 1 dose escalation trial as a weekly infusion for 3 consecutive weeks in patients with advanced solid tumours

2010 ◽  
Vol 46 (4) ◽  
pp. 729-734 ◽  
Author(s):  
N. Isambert ◽  
M. Campone ◽  
E. Bourbouloux ◽  
M. Drouin ◽  
A. Major ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Phase 1 ◽  
Solid Tumours ◽  
Weekly Infusion

scholarly journals Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial

The Lancet ◽  
2012 ◽  
Vol 379 (9829) ◽  
pp. 1893-1901 ◽  
Author(s):  
Gerald S Falchook ◽  
Georgina V Long ◽  
Razelle Kurzrock ◽  
Kevin B Kim ◽  
Tobias H Arkenau ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Dose Escalation ◽  
Phase 1 ◽  
Solid Tumours

Tolerability, safety, pharmacokinetics, and efficacy of doxorubicin-loaded anti-EGFR immunoliposomes in advanced solid tumours: a phase 1 dose-escalation study

2012 ◽  
Vol 13 (12) ◽  
pp. 1234-1241 ◽  
Author(s):  
Christoph Mamot ◽  
Reto Ritschard ◽  
Andreas Wicki ◽  
Gregor Stehle ◽  
Thomas Dieterle ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Phase 1 ◽  
Solid Tumours ◽  
Dose Escalation Study

scholarly journals First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours

2020 ◽  
Vol 123 (12) ◽  
pp. 1730-1736 ◽  
Author(s):  
Malaka Ameratunga ◽  
Irene Braña ◽  
Petri Bono ◽  
Sophie Postel-Vinay ◽  
Ruth Plummer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Dose Escalation ◽  
Phase 1 ◽  
Solid Tumours ◽  
Trial Registration ◽  
Therapeutic Window ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Bet Inhibitor ◽  
Dose Limiting Toxicity

Abstract Background Bromodomain and extra-terminal domain (BET) proteins are reported to be epigenetic anti-cancer drug targets. This first-in-human study evaluated the safety, pharmacokinetics and preliminary anti-tumour activity of the BET inhibitor ODM-207 in patients with selected solid tumours. Methods This was an open-label Phase 1 study comprised of a dose escalation part, and evaluation of the effect of food on pharmacokinetics. ODM-207 was administered orally once daily. The dose escalation part was initiated with a dose titration in the initial cohort, followed by a 3 + 3 design. Results Thirty-five patients were treated with ODM-207, of whom 12 (34%) had castrate-resistant prostate cancer. One dose-limiting toxicity of intolerable fatigue was observed. The highest studied dose achieved was 2 mg/kg due to cumulative toxicity observed beyond the dose-limiting toxicity (DLT) treatment window. Common AEs included thrombocytopenia, asthenia, nausea, anorexia, diarrhoea, fatigue, and vomiting. Platelet count decreased proportionally to exposure with rapid recovery upon treatment discontinuation. No partial or complete responses were observed. Conclusions ODM-207 shows increasing exposure in dose escalation and was safe at doses up to 2 mg/kg but had a narrow therapeutic window. Clinical trial registration The clinical trial registration number is NCT03035591.

scholarly journals Bosutinib plus capecitabine for selected advanced solid tumours: results of a phase 1 dose-escalation study

2014 ◽  
Vol 111 (11) ◽  
pp. 2058-2066 ◽  
Author(s):  
S J Isakoff ◽  
D Wang ◽  
M Campone ◽  
A Calles ◽  
E Leip ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Phase 1 ◽  
Solid Tumours ◽  
Dose Escalation Study

scholarly journals Safety and tolerability of CFI-400945, a first-in-class, selective PLK4 inhibitor in advanced solid tumours: a phase 1 dose-escalation trial

2019 ◽  
Vol 121 (4) ◽  
pp. 318-324 ◽  
Author(s):  
Zachary W. Veitch ◽  
David W. Cescon ◽  
Trisha Denny ◽  
Lisa-Maria Yonemoto ◽  
Graham Fletcher ◽  
...  
Keyword(s):  
Dose Escalation ◽  
Phase 1 ◽  
Solid Tumours
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