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Last Updated: March 28, 2020

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CLINICAL TRIALS PROFILE FOR GRANISOL

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All Clinical Trials for GRANISOL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00450801 R-MACLO-IVAM and Thalidomide in Untreated Mantle Cell Lymphoma Completed University of Miami Phase 2 2004-04-01 RATIONALE: To evaluate the efficacy of a new high intensity chemotherapy regimen with thalidomide maintenance in patients with newly diagnosed mantle cell lymphoma PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy followed by thalidomide works in treating patients with previously untreated mantle cell lymphoma.
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 GRANISOL

Condition Name

Condition Name for GRANISOL
Intervention Trials
Chemotherapy-induced Nausea and Vomiting 3
Lymphoma 1
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Condition MeSH

Condition MeSH for GRANISOL
Intervention Trials
Vomiting 3
Nausea 3
Lymphoma, Mantle-Cell 1
Lymphoma 1
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Clinical Trial Locations for GRANISOL

Trials by Country

Trials by Country for GRANISOL
Location Trials
United States 4
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Trials by US State

Trials by US State for GRANISOL
Location Trials
Massachusetts 3
Florida 1
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Clinical Trial Progress for GRANISOL

Clinical Trial Phase

Clinical Trial Phase for GRANISOL
Clinical Trial Phase Trials
Phase 3 3
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for GRANISOL
Clinical Trial Phase Trials
Completed 4
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Clinical Trial Sponsors for GRANISOL

Sponsor Name

Sponsor Name for GRANISOL
Sponsor Trials
Tesaro, Inc. 3
University of Miami 1
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Sponsor Type

Sponsor Type for GRANISOL
Sponsor Trials
Industry 3
Other 1
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Serving leading biopharmaceutical companies globally:

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