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|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Onatasertib||CC-223|ATG-008||mTOR Inhibitor 51||Onatasertib (CC-223) is a selective inhibitor of mTOR that induces apoptosis and growth inhibition in tumor cells (PMID: 25855786, PMID: 31527867).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||neuroendocrine tumor||not applicable||Onatasertib||Phase Ib/II||Actionable||In a Phase Ib/II trial, treatment with Onatasertib (CC-223) in patients with well-differentiated neuroendocrine tumors of non-pancreatic gastrointestinal or unknown origin resulted in a partial response in 7.3% (3/41) of patients, stable disease in 82.9% (34/41), a median progression-free survival of 19.5 months, and tumor shrinkage in 73.2% (30/41) (PMID: 31527867).||31527867|
|Unknown unknown||Advanced Solid Tumor||not applicable||Onatasertib||Phase I||Actionable||In a Phase I clinical trial, CC-223 demonstrated safety and some efficacy in patients with solid tumors (J Clin Oncol 31, 2013 (suppl; abstr 2606).||detail...|
|PIK3CA mutant||Advanced Solid Tumor||sensitive||Onatasertib||Phase I||Actionable||In a Phase I trial, CC-223 demonstrated safety and preliminary efficacy in patients with solid tumors, including stable disease for greater than 110 days in 2 patients with PIK3CA mutation or PTEN deletion (PMID: 26177599).||26177599 detail...|
|Unknown unknown||colon adenocarcinoma||not applicable||Onatasertib||Phase I||Actionable||In a Phase I trial, CC-223 demonstrated safety and some efficacy in patients with solid tumors, including colon cancer (J Clin Oncol 31, 2013 (suppl; abstr 2606).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT01177397||Phase Ib/II||Onatasertib||Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma||Completed||USA||3|