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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
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First-in-human phase 1/1b study to evaluate sitravatinib in patients with advanced solid tumors.

Todd Bauer1, Byong Chul Cho2, Rebecca Heist3

  • 1Department of Drug Development, Sarah Cannon Research Institute, Tennessee Oncology, 250 25th Ave North, Ste 100, Nashville, TN, 37203, USA. tbauer@tnonc.com.

Investigational New Drugs
|June 29, 2022
PubMed
Summary

Sitravatinib, a novel receptor tyrosine kinase inhibitor, showed manageable safety and modest clinical activity in advanced solid tumors during its first-in-human phase 1/1b study. The recommended dose was determined to be 120 mg daily.

Keywords:
Advanced solid tumorsAdverse eventsObjective response ratePharmacokineticsSitravatinib

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Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Sitravatinib (MGCD516) is a receptor tyrosine kinase inhibitor targeting TAM and split kinase families.
  • It has shown preclinical anti-tumor effects and ability to modulate the tumor microenvironment.

Purpose of the Study:

  • To assess the safety, pharmacokinetics, and clinical activity of sitravatinib in a first-in-human phase 1/1b study.
  • To determine the recommended dose for further investigation and explore patient selection biomarkers.

Main Methods:

  • Phase 1 involved dose exploration (10-200 mg) in 32 patients with advanced solid tumors.
  • Phase 1b dose expansion included 161 patients, evaluating 150 mg and 120 mg doses.
  • Safety, tolerability, pharmacokinetics, and objective response rates were assessed.

Main Results:

  • Maximum tolerated dose was 150 mg daily; 120 mg was the recommended dose for phase 1b due to tolerability.
  • 90.2% of patients experienced treatment-related adverse events (TRAEs), with diarrhea and fatigue being most common.
  • Overall objective response rate was 11.8% in phase 1b, with higher rates in non-small cell lung cancer (NSCLC) patients.

Conclusions:

  • Sitravatinib demonstrated a manageable safety profile and modest clinical activity in patients with advanced solid tumors.
  • The study identified 120 mg as the recommended dose and highlighted potential activity in NSCLC.