While many clinical trials for sarcomas have been performed over the past 17В years, a review of the phase I and II clinical trials for sarcomas has the potential to provide great insight into the drug discovery and development process for sarcoma. Novel drugs are tested for safety and efficacy in clinical trials prior to use in clinical practice.

5, 6ДЄlthough other cancers such as lymphoma, melanoma, lung cancer, and breast cancer have undergone treatment revolutions that have resulted in improved patient outcomes over the past two decades, 7, 8, 9, 10 there have been few advances in the treatment and outcomes of sarcoma patients besides the development of targeted therapies for gastrointestinal stromal tumors (GIST). 1, 2 Although difficult to generalize, most patients with sarcomas have poor prognoses, with 5В year survival rates between 54% and 80% for patients without metastatic disease 3, 4 and 4%вЂђ27% for patients presenting with metastatic disease. 1, 2 Sarcomas are heterogeneous, with over 60 different known subtypes. Sarcomas are rare mesenchymal derived cancers of the bones and soft tissues, with 11В 000 incident cases of soft tissue sarcoma (STS) and 3000 incident cases of bone sarcoma occurring each year in the United States. Most trials tended to group different sarcoma subtypes rather than studying each subtype separately. There was a high rate of drugs approved for other cancers and then secondarily tested in sarcoma. Approximately 90% (214/238) of studies tested drugs that were not initially tested in sarcoma, and 60.1% (143/238) of studies grouped different sarcoma histological subtypes together in the same study.ConclusionIndustry has funded the majority of phase I and II sarcoma clinical trials that have led to phase III trials.

Only 5% (12/238) of phase I and II trials resulted in phase III trials, with 11 of 12 studies funded by industry. Recorded outcomes included tested drugs, tested histological subtypes, whether the drug was initially developed for sarcoma, reported funding sources, and whether studies led to phase III trials.ResultsOut of 238 studies meeting inclusion criteria, 87% (207 studies) reported funding sources. A review of phase I and II clinical trials for sarcomas may give insight into factors influencing sarcoma drug development.MethodsAn exhaustive analysis of phase I and II clinical trials testing drugs for human sarcoma patients between 1 January 2000 and 1 June 2018 was performed using the PubMed search engine, the Thomson Web of Science, and the National Clinical Trials registry.

BackgroundThere has been limited progress in the development of novel therapeutics for the treatment of sarcomas.

Groove agent 3 trial