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NCT02626507 Hoffman Oncology Study# CL Gedatolisib001IRB APPROVED AS MODIFIED Jan 17, 2019Informed Consent Form to Participate in Research TITLE:Phase I Deescalation Study of Combination of Gedatolisib
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01
Determine the starting dose for the study based on preclinical data and safety considerations.
02
Ascertain the maximum tolerated dose (MTD) of the drug by gradually increasing the dosage in cohorts of patients and monitoring for any adverse effects.
03
Enroll patients in each dose cohort and closely monitor them for any signs of toxicity or adverse reactions.
04
Adjust the dose level for subsequent cohorts based on the observed toxicity and response in previous cohorts.
05
Continue dose escalation until the MTD is reached or until the desired therapeutic effect is achieved.
06
Collect and analyze data on safety, tolerability, and pharmacokinetics to determine the recommended phase II dose.

Who needs phase i dose-escalation study?

01
Pharmaceutical companies developing new drugs
02
Researchers conducting early-phase clinical trials
03
Regulatory agencies assessing the safety of new drug candidates
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Phase I dose-escalation study is a type of clinical trial that aims to determine the highest dose of a drug or treatment that can be given safely to patients.
The pharmaceutical company or research organization conducting the study is required to file the phase I dose-escalation study.
The phase I dose-escalation study is filled out by following the guidelines set by regulatory authorities and documenting the dose levels, patient responses, and any adverse effects.
The purpose of a phase I dose-escalation study is to determine the safety and tolerability of increasing doses of a drug or treatment in patients.
The phase I dose-escalation study must report the dose levels tested, patient demographics, adverse effects observed, and any dose-limiting toxicity.
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