2021
DOI: 10.1007/s00280-021-04338-7
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A phase 1, open-label, drug–drug interaction study of rucaparib with rosuvastatin and oral contraceptives in patients with advanced solid tumors

Abstract: Purpose This study aimed at evaluating the effect of rucaparib on the pharmacokinetics of rosuvastatin and oral contraceptives in patients with advanced solid tumors and the safety of rucaparib with and without coadministration of rosuvastatin or oral contraceptives. Methods Patients received single doses of oral rosuvastatin 20 mg (Arm A) or oral contraceptives ethinylestradiol 30 µg + levonorgestrel 150 µg (Arm B) on days 1 and 19 and continuous doses of… Show more

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Cited by 9 publications
(17 citation statements)
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“…No studies of rucaparib in healthy volunteers have been performed because PARP inhibitors are clastogenic [ 22 , 41 ]. Intensive PK data for rucaparib were obtained from 238 patients after administration of single or multiple doses in the following: a first-in-human phase I study [ 42 ], absolute oral bioavailability study [ 43 ] (A4991014; NCT01009190), ascending dose and food-effect phase I–II studies (Study 10) [ 44 ], mass balance study (NCT02986100) [ 45 ], hepatic impairment study (NCT03521037) [ 46 ], drug interaction studies (NCT02740712, NCT03954366) [ 47 , 48 ], and a phase I dose-escalation study in Japanese patients (RUCA-J; NCT03499444) [ 49 ]. Additionally, sparse PK data were collected from >1027 patients in Study 10 [ 44 ], ARIEL2 Part 1 [ 32 ], ARIEL3, TRITON2, and the phase III TRITON3 study (NCT02975934) of rucaparib in the mCRPC setting.…”
Section: Pharmacokinetics Of Rucaparibmentioning
confidence: 99%
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“…No studies of rucaparib in healthy volunteers have been performed because PARP inhibitors are clastogenic [ 22 , 41 ]. Intensive PK data for rucaparib were obtained from 238 patients after administration of single or multiple doses in the following: a first-in-human phase I study [ 42 ], absolute oral bioavailability study [ 43 ] (A4991014; NCT01009190), ascending dose and food-effect phase I–II studies (Study 10) [ 44 ], mass balance study (NCT02986100) [ 45 ], hepatic impairment study (NCT03521037) [ 46 ], drug interaction studies (NCT02740712, NCT03954366) [ 47 , 48 ], and a phase I dose-escalation study in Japanese patients (RUCA-J; NCT03499444) [ 49 ]. Additionally, sparse PK data were collected from >1027 patients in Study 10 [ 44 ], ARIEL2 Part 1 [ 32 ], ARIEL3, TRITON2, and the phase III TRITON3 study (NCT02975934) of rucaparib in the mCRPC setting.…”
Section: Pharmacokinetics Of Rucaparibmentioning
confidence: 99%
“…The potential for DDIs associated with rucaparib and concomitant medications have been investigated by the use of dedicated in vitro testing and clinical studies in patients with an advanced solid tumor [ 47 , 48 , 54 , 61 ].…”
Section: Drug–drug Interactionsmentioning
confidence: 99%
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