Starting dose selection and dose escalation for oncology small molecule first-in-patient trials: learnings from a survey of FDA-approved drugs

Author:

Mittapalli Rajendar K.ORCID,Yin Donghua,Beaupre Darrin,Palaparthy Rameshraja

Funder

Pfizer

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Cancer Research,Pharmacology,Toxicology,Oncology

Reference14 articles.

1. Adashek JJ, LoRusso PM, Hong DS, Kurzrock R (2019) Phase I trials as valid therapeutic options for patients with cancer. Nat Rev Clin Oncol 16(12):773–778. https://doi.org/10.1038/s41571-019-0262-9

2. EMEA/CHMP (2007) Guideline on strategies to identify and mitigate risks for fist-in-human clinical trials with investigational medicinal products

3. EMEA/CHMP (2018) Guideline on strategies to identify and mitigate risks for fist-in-human clinical trials with investigational medicinal products

4. FDA (2005) Guidance for industry. Estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers

5. ICH (2010) ICH guideline S9 on nonclinical evaluation for anticancer pharmaceuticals

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