- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01500226
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
February 2, 2016 updated by: Tesaro, Inc.
Phase 3, Multicenter, Randomized, Double Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Moderately Emetogenic Chemotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 orally 1-2 hours prior to the initiation of chemotherapy on Day 1. Granisetron (2 mg PO) and dexamethasone (20 mg PO) will be administered approximately 30 minutes before initiation of chemotherapy.
Subjects will continue to receive granisetron (2 mg daily) on Days 2 and 3. 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 and neurological examinations, vital signs, electrocardiograms (ECGs), and safety laboratory values including BUN and creatinine.
All subjects are expected to complete Cycle 1 and will have the option of participating in up to five additional cycles.
Blood samples may be collected and stored in this study and may be analyzed for future biomarker research related to safety and efficacy.
Study Type
Interventional
Enrollment (Actual)
1369
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Waltham, Massachusetts, United States, 02451
- TESARO Inc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older, of either gender, and of any race
- Naïve to moderately or highly emetogenic chemotherapy, and is to receive a first course of MEC including one or more of the following agents: cyclophosphamide IV (<1500 mg/m2), doxorubicin, epirubicin, carboplatin, idarubicin, ifosfamide, irinotecan, daunorubicin, cytarabine IV (>1 g/m2).
- Karnofsky performance score of ≥60
- Predicted life expectancy of ≥4 months
- Adequate bone marrow, kidney, and liver function
Exclusion Criteria:
- Contraindication to the administration of prescribed MEC agent,granisetron, or dexamethasone
- Is pregnant or breast feeding
- Has taken the following agents within the last 48 hours 5-HT3 antagonists,Phenothiazines,Benzamides,Domperidone,Cannabinoids,NK1 antagonist, Benzodiazepines
- Scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day 6, except on Day 1
- Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6
- Has received systemic corticosteroids or sedative antihistamines within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes)
- Symptomatic primary or metastatic CNS disease.
- Has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
- Has vomited and/or has had dry heaves/retching within 24 hours prior to the start of MECon Day 1 in Cycle 1.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo + Granisetron + Dexamethasone
Day 1: Placebo + Granisetron (2 mg PO)+ Dexamethasone (20 mg PO) Days 2-3: Granisetron (2 mg PO) will be administered orally.
|
2 mg PO
Other Names:
20 mg PO
Other Names:
(4 X 0 mg capsules) 0 mg PO
Other Names:
|
Experimental: Rolapitant
Day 1: Rolapitant (200 mg PO) + Granisetron (2 mg PO)+ Dexamethasone (20 mg PO) Days 2-3: Granisetron (2 mg PO) will be administered orally.
|
2 mg PO
Other Names:
20 mg PO
Other Names:
(4 X 50 mg capsule) 200 mg PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
No Emetic Episodes and No Rescue Medication
Time Frame: >24 to 120 hours post chemotherapy
|
The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC.
The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).
|
>24 to 120 hours post chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Phase Response
Time Frame: 0 to 24 hours
|
To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.
|
0 to 24 hours
|
Overall Response Rate
Time Frame: 0 to 120 hours
|
To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.
|
0 to 120 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dennis Vargo, MD, Tesaro, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
December 22, 2011
First Submitted That Met QC Criteria
December 27, 2011
First Posted (Estimate)
December 28, 2011
Study Record Updates
Last Update Posted (Estimate)
March 2, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Serotonin Agents
- Serotonin Antagonists
- Neurokinin-1 Receptor Antagonists
- Dexamethasone
- Granisetron
- Rolapitant
Other Study ID Numbers
- TS-P04834
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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