NCT03413176 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE
Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24. Review.
Gougis P, Wassermann J, Spano JP, Keynan N, Funck-Brentano C, Salem JE
Clinical pharmacology of anti-angiogenic drugs in oncology. Crit Rev Oncol Hematol. 2017 Nov;119:75-93. doi: 10.1016/j.critrevonc.2017.08.010. Epub 2017 Sep 1. Review.

Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.

Clinical trial NCT03413176 - References