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Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Phase 2
18 Years
Not Enrolling
Nausea, Vomiting

Thank you

Trial Information

Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting

Inclusion Criteria:

- diagnosis of cancer

- scheduled to receive a chemotherapy treatment containing at least moderately
emetogenic chemotherapy:

- chemotherapy to be given in an inpatient setting

- chemotherapy may be for adjuvant, neoadjuvant, curative or palliative intent

- patients may be treatment naive or have been treated previously with chemotherapy

- chemotherapy agents may be given orally, intravenously, or by continuous infusion on
one or multiple days

- scheduled to receive a 5-HT3 receptor antagonist antiemetic: ondansetron,
granisetron, palonosetron or dolasetron mesylate, dexamethasone with or without a
benzodiazepine on the day of treatment according to published antiemetic guidelines
or as clinically indicated

- able to understand English (all assessment instruments are in English)

- 18 years of age or older

- informed consent

- self report of at least mild nausea which the patient feels needs rescuing or
"moderate nausea" (a score of >2 on a 4 point Likert scale) or at least one episode
of emesis since receiving chemotherapy

Exclusion Criteria:

- patients who have received aprepitant as prophylaxis or rescue treatment during the
current cycle of chemotherapy

- patients who are pregnant, have positive serum hCG, or are lactating

- patients with clinical evidence of current or impending bowel obstruction (patients
with tumor pressing on their bowel) or symptomatic brain metastases

- patients receiving a scheduled dopamine antagonist after chemotherapy

- patients with an allergy to or history of intolerance of any of the study drugs will
be excluded from the study

- history of chronic nausea/vomiting without chemotherapy, history of anticipatory
nausea/vomiting, or emesis within 24 hours prior to chemotherapy starting

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary analysis will utilize a Wilcoxon signed rank test to compare the change from baseline to 2 hours post-treatment initiation.

Outcome Time Frame:

2 hours post study drug administration

Safety Issue:


Principal Investigator

Joseph Bubalo, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

February 2013

Related Keywords:

  • Nausea
  • Vomiting
  • breakthrough CINV
  • fosaprepitant
  • breakthrough chemotherapy induced nausea and vomiting
  • Nausea
  • Vomiting



OHSU Knight Cancer InstitutePortland, Oregon  97239