Citation(s)
- 1
Ezzalfani M. et al. The role of the expansion cohort in phase I trials in oncology: guidelines of the phase I HUB. Bull Cancer. 2015 Jan;102(1):73-82. doi:10.1016/j.bulcan. 2014.10.001. Epub 2015 Jan 2. Review. French. 2.M3(R2) guideline : Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 3.ICH S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals EMEA/CHMP/ICH/646107/2008 4.Masini et al. Histamin-releasing properties of polysorbate 80 in vitro and in vivo: correlation 1254 with its hypotensive action in the dog. Agents Actions 1985 Sep; 16(6):470-7. 5.Guideline on repeated dose toxicity - CPMP/SWP/1042/99 Rev 1 6.Storer B.E. Design and Analysis of Phase I Clinical Trials. Biometrics, Vol. 45, No. 3 (Sep., 1989), pp. 925-937. 7.Seshan V.E. et al. Clinical Trial Design and Data Analysis Functions, Package clinfun, version 1.0.15 (Apr 2018)
Dose Escalation, First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics and Preliminary Antitumor Activity of PEP-010, Administered as Single Agent and in Combination With Paclitaxel or With Gemcitabine in Patients With Metastatic Solid Cancer
Details for clinical trial NCT04733027