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Last Updated: June 27, 2022

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.
>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
Locally Advanced Sarcoma 1
Non Small Cell Lung Cancer 1
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Condition MeSH

Condition MeSH for Varubi
Intervention Trials
Nausea 5
Vomiting 5
Lung Neoplasms 1
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Clinical Trial Locations for Varubi

Trials by Country

Trials by Country for Varubi
Location Trials
United States 5
Turkey 1
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Trials by US State

Trials by US State for Varubi
Location Trials
Massachusetts 3
North Carolina 1
Texas 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 4
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Clinical Trial Status

Clinical Trial Status for Varubi
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Terminated 1
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Clinical Trial Sponsors for Varubi

Sponsor Name

Sponsor Name for Varubi
Sponsor Trials
Tesaro, Inc. 6
ECONiX Araştırma Analiz ve Danışmanlık A.Ş. 2
PlusVitech S.L. 2
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Sponsor Type

Sponsor Type for Varubi
Sponsor Trials
Industry 8
Other 6
NIH 1
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Serving leading biopharmaceutical companies globally:

McKesson
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Boehringer Ingelheim
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Express Scripts
Baxter

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