Phase I and pharmacokinetic study of the vascular‐disrupting agent CKD‐516 (NOV120401) in patients with refractory solid tumors
Abstract We report a phase I pharmacological study of an oral formulation of CKD‐516, a vascular‐disrupting agent, in patients with refractory solid tumors. Twenty‐seven patients (16 in the dose‐escalation cohort and 11 in the expansion cohort) received a single daily dose (5‐25 mg) of CKD‐516 five...
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Wiley,
2020-04-01T00:00:00Z.
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| 100 | 1 | 0 | |a Hark Kyun Kim |e author |
| 700 | 1 | 0 | |a Jeong Won Kang |e author |
| 700 | 1 | 0 | |a Young‐Whan Park |e author |
| 700 | 1 | 0 | |a Jung Young Kim |e author |
| 700 | 1 | 0 | |a Minchae Kim |e author |
| 700 | 1 | 0 | |a Soo Jin Kim |e author |
| 700 | 1 | 0 | |a Se‐mi Kim |e author |
| 700 | 1 | 0 | |a Keun Ho Ryu |e author |
| 700 | 1 | 0 | |a Seonghae Yoon |e author |
| 700 | 1 | 0 | |a Yun Kim |e author |
| 700 | 1 | 0 | |a Joo‐Youn Cho |e author |
| 700 | 1 | 0 | |a Keun Seok Lee |e author |
| 700 | 1 | 0 | |a Tak Yun |e author |
| 700 | 1 | 0 | |a Kiwon Kim |e author |
| 700 | 1 | 0 | |a Mi Hyang Kwak |e author |
| 700 | 1 | 0 | |a Tae‐Sung Kim |e author |
| 700 | 1 | 0 | |a Jinsoo Chung |e author |
| 700 | 1 | 0 | |a Joong‐Won Park |e author |
| 245 | 0 | 0 | |a Phase I and pharmacokinetic study of the vascular‐disrupting agent CKD‐516 (NOV120401) in patients with refractory solid tumors |
| 260 | |b Wiley, |c 2020-04-01T00:00:00Z. | ||
| 500 | |a 2052-1707 | ||
| 500 | |a 10.1002/prp2.568 | ||
| 520 | |a Abstract We report a phase I pharmacological study of an oral formulation of CKD‐516, a vascular‐disrupting agent, in patients with refractory solid tumors. Twenty‐seven patients (16 in the dose‐escalation cohort and 11 in the expansion cohort) received a single daily dose (5‐25 mg) of CKD‐516 five days per week. Nausea (67%) and diarrhea (63%) were the most common treatment‐related adverse events. The recommended phase II dose of oral CKD‐516 was 20 mg/d (15 mg/d with a body surface area (BSA) <1.65 m2). Notably, S‐516 half‐lives in patients receiving 15‐20 mg CKD‐516/d significantly differed between patients with and without splenomegaly that is suggestive of portal hypertension associated with liver cirrhosis (6.1 vs 4.6 hours, respectively). Of 11 patients without splenomegaly who completed at least one cycle of a daily CKD‐516 dose of either 15 or 20 mg, only one patient (9.1%) suffered from any dose‐limiting toxicity. We conclude that a daily oral dose of 15 or 20 mg CKD‐516 five days per week could be tolerable in patients without liver cirrhosis. | ||
| 546 | |a EN | ||
| 690 | |a cancer | ||
| 690 | |a phase 1 trial | ||
| 690 | |a vascular | ||
| 690 | |a Therapeutics. Pharmacology | ||
| 690 | |a RM1-950 | ||
| 655 | 7 | |a article |2 local | |
| 786 | 0 | |n Pharmacology Research & Perspectives, Vol 8, Iss 2, Pp n/a-n/a (2020) | |
| 787 | 0 | |n https://doi.org/10.1002/prp2.568 | |
| 787 | 0 | |n https://doaj.org/toc/2052-1707 | |
| 856 | 4 | 1 | |u https://doaj.org/article/ccb88be43f3f4ae6a262e4a50e8c051a |z Connect to this object online. |