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Last Updated: May 13, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR VARUBI

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All Clinical Trials for Varubi

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01499849 Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy Completed Tesaro, Inc. Phase 3 2012-02-01 This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT01500213 Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy Completed Tesaro, Inc. Phase 3 2012-02-01 This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving HEC. Rolapitant or placebo will be administered 1-2 hours prior to initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to HEC administration through Day 6 of Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT01500226 Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy Completed Tesaro, Inc. Phase 3 2012-02-01 This is a Phase 3, multicenter, randomized, parallel-group, double-blind, active-controlled study of rolapitant in subjects receiving MEC. Rolapitant or placebo will be administered prior to the initiation of chemotherapy on Day 1 with granisetron and dexamethasone. Subjects will record all events of emesis and the use of rescue medication for established nausea and/or vomiting, and will indicate the severity of nausea they experienced in each of the previous 24 hours in the Nausea and Vomiting (NV) Subject Diary prior to the MEC administration through Day 6 in Cycle 1. Health-related quality of life will be measured by the FLIE Questionnaire on Day 6 of Cycle 1. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examination, electrocardiograms (ECGs), and safety laboratory values. All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
NCT02991456 Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide Not yet recruiting Tesaro, Inc. Phase 2 2017-01-01 The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.
NCT02991456 Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide Not yet recruiting Duke University Phase 2 2017-01-01 The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.
NCT03960151 Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy Withdrawn Tesaro, Inc. Phase 2 2018-05-01 Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
NCT03960151 Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy Withdrawn Costantine Albany Phase 2 2018-05-01 Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Varubi

Condition Name

Condition Name for Varubi
Intervention Trials
Chemotherapy-induced Nausea and Vomiting 3
Non Small Cell Lung Cancer 1
Germ Cell Tumor 1
Chemo-radiation Induced Nausea and Vomiting 1
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Condition MeSH

Condition MeSH for Varubi
Intervention Trials
Nausea 4
Vomiting 4
Lung Neoplasms 1
Carcinoma, Non-Small-Cell Lung 1
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Clinical Trial Locations for Varubi

Trials by Country

Trials by Country for Varubi
Location Trials
United States 4
Turkey 1
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Trials by US State

Trials by US State for Varubi
Location Trials
Massachusetts 3
North Carolina 1
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Clinical Trial Progress for Varubi

Clinical Trial Phase

Clinical Trial Phase for Varubi
Clinical Trial Phase Trials
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Varubi
Clinical Trial Phase Trials
Completed 3
Withdrawn 1
Not yet recruiting 1
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Clinical Trial Sponsors for Varubi

Sponsor Name

Sponsor Name for Varubi
Sponsor Trials
Tesaro, Inc. 5
ECONiX Araştırma Analiz ve Danışmanlık A.Ş. 1
PlusVitech S.L. 1
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Sponsor Type

Sponsor Type for Varubi
Sponsor Trials
Industry 6
Other 3
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Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Mallinckrodt
McKesson
Express Scripts
Baxter

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