Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00337727
First received: June 14, 2006
Last updated: March 14, 2013
Last verified: March 2013
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Purpose
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
| Condition | Intervention | Phase |
|---|---|---|
|
Chemotherapy-Induced Nausea and Vomiting |
Drug: aprepitant Drug: Comparator: ondansetron Drug: Comparator: dexamethasone Drug: Comparator: fosaprepitant dimeglumine Drug: Comparator; Placebo (unspecified) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC) |
Resource links provided by NLM:
MedlinePlus related topics:
Nausea and Vomiting
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Ondansetron hydrochloride
Ondansetron
Aprepitant
Fosaprepitant
Fosaprepitant dimeglumine
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Number of Patients Who Reported No Vomiting [ Time Frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1. ] [ Designated as safety issue: No ]
The number of patients who reported No Vomiting in the overall phase in Cycle
1
Secondary Outcome Measures:
- Number of Patients Who Reported Complete Response [ Time Frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1 ] [ Designated as safety issue: No ]The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.
| Enrollment: | 848 |
| Study Start Date: | January 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours.
|
Drug: aprepitant
aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
Other Name: MK0869
Drug: Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
Other Name: Zofran®
Drug: Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Other Name: DEXAMETHASONE TABLETS USP
Drug: Comparator; Placebo (unspecified)
dexamethasone 12mg Pbo tablets.
|
|
2
Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.
|
Drug: Comparator: ondansetron
Ondansetron 8 mg capsule Three day treatment period.
Other Name: Zofran®
Drug: Comparator: dexamethasone
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Other Name: DEXAMETHASONE TABLETS USP
Drug: Comparator: fosaprepitant dimeglumine
fosaprepitant dimeglumine 115 mg
Other Name: EMEND®
Drug: Comparator; Placebo (unspecified)
Aprepitant 80 mg & 125 mg Pbo capsules.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
- Karnofsky score of 60 or greater
Exclusion Criteria:
- Patient is scheduled to receive any dose of cisplatin
- Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
- Any allergies to study drug or antiemetics
- Taking CYP3A4 substrates/prohibited medication
- Significant medical or mental conditions
- Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT00337727 History of Changes |
| Other Study ID Numbers: | MK-0869-130, 2006_016 |
| Study First Received: | June 14, 2006 |
| Results First Received: | September 30, 2009 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms Dexamethasone acetate Dexamethasone Ondansetron Aprepitant Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antipruritics Dermatologic Agents Serotonin Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013