Fosaprepitant (EMEND® IV) In Salvage Treatment of Chemotherapy-Induced Vomiting (MK-0517-030 AM1) (EVADE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01405924
First received: July 28, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

This study will assess the efficacy of a single dose of fosaprepitant as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC).


Condition Intervention Phase
Nausea
Vomiting
Drug: fosaprepitant dimeglumine
Drug: 5HT3 RA
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Overall proportion of participants with no vomiting or retching [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with no vomiting or retching per type of chemotherapy [ Time Frame: Up to 120 hours following initiation of chemotherapy ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breast Cancers
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy
Drug: fosaprepitant dimeglumine
150 mg intravenously (IV) on Day 1 of chemotherapy
Other Name: MK-0517, EMEND® IV
Drug: 5HT3 RA
5HT3 RA will be administered at the same dosage used in the first cycle of chemotherapy
Drug: dexamethasone
dexamethasone will be administered at the same dosage used in the first cycle of chemotherapy
Experimental: Gynecological Cancers
Women with breast cancer receiving carboplatin-paclitaxel chemotherapy
Drug: fosaprepitant dimeglumine
150 mg intravenously (IV) on Day 1 of chemotherapy
Other Name: MK-0517, EMEND® IV
Drug: 5HT3 RA
5HT3 RA will be administered at the same dosage used in the first cycle of chemotherapy
Drug: dexamethasone
dexamethasone will be administered at the same dosage used in the first cycle of chemotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with either breast or gynecological cancer
  • Receiving either AC-like or carboplatin-paclitaxel MEC
  • Experienced at least 1 episode of vomiting or retching during the first 5 days following cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant
  • No change in chemotherapy at cycle 2
  • No change in cycle 1 antiemetic regimen at cycle 2
  • Eastern Cooperative Oncology Group (ECOG) status 0-1

Exclusion Criteria:

  • Requires increase in systemic corticosteroid therapy
  • Used benzodiazepines or opiates in the 48 hours prior to cycle 2 chemotherapy
  • Received or will receive radiation therapy to the abdomen or pelvis in the week prior to visit 1 or in days 1-6 following chemotherapy
  • Vomited in the 24 hours prior to Treatment Day 1
  • Pregnant or breast-feeding
  • Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks
  • Symptomatic central nervous system metastasis
  • History of other malignancies in the last 2 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01405924     History of Changes
Other Study ID Numbers: 0517-030
Study First Received: July 28, 2011
Last Updated: January 23, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Fosaprepitant
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
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014