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Rolapitant

DRUG7 trials

Sponsors

Tesaro, Inc., Duke University, Costantine Albany

Conditions

Chemo-radiation Induced Nausea and VomitingChemotherapy-induced Nausea and VomitingGerm Cell Tumor

Phase 1

A Phase 1, 2-Part, Single Ascending Dose Assessment of the Safety, Tolerability, and Pharmacokinetics of Rolapitant Intravenous in Healthy Volunteers
CompletedNCT02382666
Tesaro, Inc.Chemotherapy-induced Nausea and Vomiting
Start: 2015-01-31End: 2015-08-31Updated: 2015-08-25
An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects
CompletedNCT02434861
Tesaro, Inc.Chemotherapy-induced Nausea and Vomiting
Start: 2015-05-31End: 2015-08-31Updated: 2015-08-25

Phase 2

Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide
CompletedNCT02991456
Duke UniversityChemo-radiation Induced Nausea and Vomiting
Start: 2017-10-09End: 2022-06-20Updated: 2023-07-11
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
WithdrawnNCT03960151
Costantine AlbanyGerm Cell Tumor
Start: 2018-05-31End: 2022-03-31Updated: 2019-05-22

Phase 3

Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
CompletedNCT01499849
Tesaro, Inc.Chemotherapy-induced Nausea and Vomiting
Start: 2012-02-29End: 2014-05-31Updated: 2016-05-19
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
CompletedNCT01500213
Tesaro, Inc.Chemotherapy-induced Nausea and Vomiting
Start: 2012-02-29End: 2014-03-31Updated: 2016-03-02
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
CompletedNCT01500226
Tesaro, Inc.Chemotherapy-induced Nausea and Vomiting
Start: 2012-02-29End: 2014-02-28Updated: 2016-03-02

Related Papers

Rolapitant for the prevention of nausea in patients receiving moderately or highly emetogenic chemotherapy.
Journal of Clinical Oncology2016-10-092 citations
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.
Journal of Clinical Oncology2016-10-092 citations
Efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gastrointestinal and colorectal cancers.
Journal of Clinical Oncology2016-10-091 citations
Rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer.
Journal of Clinical Oncology2016-05-202 citations
Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.
Journal of Clinical Oncology2016-05-202 citations
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients (pts) receiving anthracycline-cyclophosphamide (AC)-based chemotherapy.
Journal of Clinical Oncology2015-10-102 citations
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) over multiple cycles of highly or moderately emetogenic chemotherapy (HEC, MEC).
Journal of Clinical Oncology2015-10-101 citations
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in non–anthracycline/cyclophosphamide (AC)-based moderately emetogenic therapy (MEC).
Journal of Clinical Oncology2015-10-10
Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide regimens in patients with cancer: a randomised, active-controlled, double-blind, phase 3 trial.
2015-08-1097 citations
Safety and efficacy of rolapitant for prevention of chemotherapy-induced nausea and vomiting after administration of cisplatin-based highly emetogenic chemotherapy in patients with cancer: two randomised, active-controlled, double-blind, phase 3 trials.
2015-08-1093 citations
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in moderately emetogenic therapy (MEC).
Journal of Clinical Oncology2015-05-205 citations
Impact of rolapitant on quality of life (QoL) in patients (pts) receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).
Journal of Clinical Oncology2015-05-202 citations
Efficacy and safety of rolapitant for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients (pts) receiving anthracycline-cyclophosphamide (AC)-based chemotherapy.
Journal of Clinical Oncology2015-05-20
Phase 3 trial results for rolapitant, a novel NK-1 receptor antagonist, in the prevention of chemotherapy-induced nausea and vomiting (CINV) in subjects receiving moderately emetogenic chemotherapy (MEC).
Journal of Clinical Oncology2014-05-2013 citations
Safety of rolapitant, a novel NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately or highly emetogenic chemotherapy (MEC or HEC).
Journal of Clinical Oncology2014-05-208 citations
Phase 3 trial results for rolapitant, a novel NK-1 receptor antagonist, in the prevention of chemotherapy-induced nausea and vomiting (CINV) in subjects receiving highly emetogenic chemotherapy (HEC).
Journal of Clinical Oncology2014-05-206 citations