Therapy Detail
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| Therapy Name | Onatasertib |
| Synonyms | |
| Therapy Description |
CC-223 is a selective inhibitor of mTOR that induces apoptosis and growth inhibition in tumor cells (PMID: 25855786). |
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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). |
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| 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... |
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| 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 |
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