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|Therapy Name||Carboplatin + Etoposide + Roniciclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Carboplatin||Paraplatin||CBDCA||Chemotherapy - Platinum 6||Paraplatin (carboplatin) is a second-generation platinum compound and is activated intracellularly to form reactive platinum complexes that cross link DNA with DNA and with proteins. This induces apoptosis and inhibits cell growth (NCI Drug Dictionary).|
|Etoposide||Vepesid||EPEG|Eposin|VP-16|VP-16-213||TOPO2 inhibitor 4||Vepesid (etoposide) binds to and inhibits DNA topoisomerase II, resulting in accumulated DNA damage, inhibition of replication, and cell death (NCI Drug Dictionary).|
|Roniciclib||BAY1000394|BAY10-00394|BAY 10-00394||CDK Inhibitor (Pan) 4||Roniciclib (BAY1000394) is a pan-CDK inhibitor that induces cell-cycle arrest and apoptosis, resulting in inhibition of tumor cell growth (PMID: 22821149, PMID: 30677506).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||lung small cell carcinoma||not applicable||Carboplatin + Etoposide + Roniciclib||Phase II||Actionable||In a Phase II trial, the combination of Roniciclib (BAY1000394) plus chemotherapy regimen, Paraplatin (carboplatin) or Platinol (cisplatin) and Vepesid (etoposide) (n=71), did not meet its primary endpoint for progression-survival in patients with small cell lung cancer (4.9 mo vs 5.5 mo) when compared to placebo plus chemotherapy (n=71), and showed an unfavorable risk-benefit profile, therefore, leading to premature termination of the study (PMID: 30677506; NCT02161419).||30677506|
|Unknown unknown||lung small cell carcinoma||not applicable||Carboplatin + Etoposide + Roniciclib||Phase Ib/II||Actionable||In a Phase Ib/II trial, first-line treatment with the combination of Roniciclib (BAY1000394) and either carboplatin plus etoposide or cisplatin plus etoposide demonstrated tolerability and resulted in a response rate of 81.4% (35/43; all partial responses), median OS of 12.6 mo, and median PFS of 7.3 mo in extensive disease small cell lung cancer patients; however due to a safety signal in a related trial further development of Roniciclib (BAY1000394) was discontinued (PMID: 30089585; NCT01573338).||30089585|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|