Last updated: 11/04/2018 09:47:34
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase II Multicenter, Randomized, Double-Blind, Placebo-controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered as 50 mg, 100 mg, and 150 mg Oral Tablets in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy
Trial description: This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants who achieved a complete response, 0-120 hours (h)
Timeframe: Up to 120 h
Number of participants experiencing significant nausea during the 120 h
Timeframe: Up to 120 h
Secondary outcomes:
Number of participants who achieved a complete response during the acute (0–24 h) and delayed (24–120 h)
Timeframe: Up to 120 h
Number of participants who achieved complete protection during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants with significant nausea during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants who received rescue medication during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants with Time to emesis and Time to first rescue medication
Timeframe: Up to Day 10
Number of participants with total control during 0–120 h
Timeframe: Up to 120 h
Number of participants with vomiting during the acute (0–24 h), delayed (24–120 h) and overall (0–120 h)
Timeframe: Up to 120 h
Number of participants with nausea during 0–120 h
Timeframe: Up to 120 h
Number of participants with Clinically significant change from Baseline in electrocardiogram (ECG) values
Timeframe: Baseline (Day 1) and up to Day 30
Mean systolic and diastolic blood pressure (SBP and DBP) over period
Timeframe: Up to Day 30 and Day 1 of Each Subsequent Cycle
Mean heart rate over period
Timeframe: Up to Day 30 and Day 1 of each Subsequent Cycle
Mean respiration rate over period
Timeframe: Up to Day 30
Number of participants with Hematological parameters outside the reference range
Timeframe: Up to Day 30
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: AEs and SAEs were collected approximately up to 4 cycles (4 months)
Number of participants with response to Functional Living Index - Emesis (FLIE) questionnaire over 0-120 h
Timeframe: Day 1 and Day 6 – 10 Visit
Number of participants with satisfaction response with respect to the control of Chemotherapy-induced nausea and vomiting (CINV)
Timeframe: Up to Day 30
Interventions:
Enrollment:
723
Primary completion date:
2006-12-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009 Dec 15;115(24):5807-16. doi: 10.1002/cncr.24630.
Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009;115(24):5807-16.
Medical condition
Chemotherapy-Induced Nausea and Vomiting
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
December 2004 to January 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumor and has not previously received chemotherapy.
- Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. Exclusion criteria:
- Not received any investigational product within 30 days of enrollment into the study.
- Must not be pregnant.
- Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
- Must not have a history of peptic ulcer disease.
Trial location(s)
Location
GSK Investigational Site
New Albany, Indiana, United States, 47150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bay City, Michigan, United States, 48708
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2006-12-01
Actual study completion date
2006-12-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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