PMID- 38271925
OWN - NLM
STAT- Publisher
LR  - 20240125
IS  - 2005-9256 (Electronic)
IS  - 1598-2998 (Linking)
DP  - 2024 Jan 18
TI  - Phase 1/2a Study of Rivoceranib, a Selective VEGFR-2 Angiogenesis Inhibitor, in 
      Patients with Advanced Solid Tumors.
LID - 10.4143/crt.2023.980 [doi]
AB  - PURPOSE: To report the results from an early-phase study of rivoceranib, an oral 
      tyrosine kinase inhibitor highly selective for vascular endothelial growth factor 
      receptor 2, in patients with advanced solid tumors. MATERIALS AND METHODS: In 
      this open-label, single-arm, dose-escalating, multicenter three-part phase 1/2a 
      trial, patients had advanced solid tumors refractory to conventional therapy. 
      Part 1 evaluated the safety and pharmacokinetics of five ascending once-daily 
      doses of rivoceranib from 81 mg to 685 mg. Part 2 evaluated the safety and 
      antitumor activity of once-daily rivoceranib 685 mg. Part 3 was conducted later, 
      due to lack of MTD determination in part 1, to evaluate the safety and 
      preliminary efficacy of once-daily rivoceranib 805 mg in patients with 
      unresectable or advanced gastric cancer. RESULTS: A total of 61 patients were 
      enrolled in parts 1 (n=25), 2 (n=30), and 3 (n=6). In parts 1 and 2, patients 
      were white (45.5%) or Asian (54.5%), and 65.6% were male. The most common grade 
      >/=3 adverse events (AEs) were hypertension (32.7%), hyponatremia (10.9%), and 
      hypophosphatemia (10.9%). The overall response rate (ORR) was 15.2%. In part 3, 
      dose-limiting toxicities occurred in 2 out of 6 patients: grade 3 febrile 
      neutropenia decreased appetite, and fatigue. The ORR was 33%. CONCLUSION: The 
      recommended phase 2 dose of rivoceranib was determined to be 685 mg once daily, 
      which showed adequate efficacy with a manageable safety profile. (NCT01497704 and 
      NCT02711969).
FAU - Kang, Yoon-Koo
AU  - Kang YK
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Ryu, Min-Hee
AU  - Ryu MH
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Hong, Yong Sang
AU  - Hong YS
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Choi, Chang-Min
AU  - Choi CM
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Kim, Tae Won
AU  - Kim TW
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Ryoo, Baek-Yeol
AU  - Ryoo BY
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Kim, Jeong Eun
AU  - Kim JE
AD  - Department of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Weis, John R
AU  - Weis JR
AD  - University of Utah and Huntsman Cancer Institute, Salt Lake City, UT, USA.
FAU - Kingsford, Rachel
AU  - Kingsford R
AD  - University of Utah and Huntsman Cancer Institute, Salt Lake City, UT, USA.
FAU - Park, Cheol Hee
AU  - Park CH
AD  - Elevar Therapeutics, Fort Lee, NJ, USA.
FAU - Jang, Seong
AU  - Jang S
AD  - Elevar Therapeutics, Fort Lee, NJ, USA.
FAU - McGinn, Arlo
AU  - McGinn A
AD  - Elevar Therapeutics, Fort Lee, NJ, USA.
FAU - Werner, Theresa L
AU  - Werner TL
AD  - University of Utah and Huntsman Cancer Institute, Salt Lake City, UT, USA.
FAU - Sharma, Sunil
AU  - Sharma S
AD  - Translational Genomics Research Institute, Phoenix, AZ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02711969
SI  - ClinicalTrials.gov/NCT01497704
PT  - Journal Article
DEP - 20240118
PL  - Korea (South)
TA  - Cancer Res Treat
JT  - Cancer research and treatment
JID - 101155137
SB  - IM
OTO - NOTNLM
OT  - Apatinib
OT  - Rivoceranib
OT  - Solid tumors
OT  - Stomach neoplasms
EDAT- 2024/01/26 00:44
MHDA- 2024/01/26 00:44
CRDT- 2024/01/25 18:09
PHST- 2023/08/29 00:00 [received]
PHST- 2024/01/17 00:00 [accepted]
PHST- 2024/01/26 00:44 [medline]
PHST- 2024/01/26 00:44 [pubmed]
PHST- 2024/01/25 18:09 [entrez]
AID - crt.2023.980 [pii]
AID - 10.4143/crt.2023.980 [doi]
PST - aheadofprint
SO  - Cancer Res Treat. 2024 Jan 18. doi: 10.4143/crt.2023.980.