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|Therapy Name||Cyclophosphamide + Lorlatinib + Topotecan|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cyclophosphamide||Cytoxan||CPM||Chemotherapy - Alkylating 17||Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary).|
|Lorlatinib||Lorbrena||PF-06463922|Lorviqua||ALK Inhibitor 31 ROS1 Inhibitor 20||Lorbrena (lorlatinib) is a small molecule inhibitor of Alk and Ros1 fusion proteins, which may result in suppression of Alk and Ros1-mediated signaling thereby inhibiting cell growth and causing tumor regression (PMID: 26144315). Lorbrena (lorlatinib) is FDA approved for use in patients with ALK-positive non-small cell lung cancer (FDA.gov).|
|Topotecan||Hycamtin||Topotecan Hcl||Topotecan binds to topoisomerase I and stablizes complexes with DNA, resulting in decreased repair of DNA single-strand breaks, and potentially leading to cell death (NCI Drug Dictionary).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|ALK act mut||neuroblastoma||sensitive||Cyclophosphamide + Lorlatinib + Topotecan||Phase I||Actionable||In a Phase I trial, the combination of Lorbrena (lorlatinib), Topotecan, and Cytoxan (cyclophosphamide) treatment was well tolerated and resulted in a modified response rate of 63% (5/8) in pediatric patients with neuroblastoma harboring an ALK activating mutation, including ALK F1174C, F1174L, R1275Q, or R1275L (PMID: 37012551; NCT03107988).||37012551|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03107988||Phase I||Cyclophosphamide + Lorlatinib + Topotecan Lorlatinib||NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922)||Active, not recruiting||USA | GBR | FRA | CAN||0|