Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

NCT00337727 | Completed Phase 3 Results

• 2 other identifiers: 0869-1302006_016
• Study Type: interventional
• Target: 848
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chemotherapy-Induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Reported No Vomiting

  The number of patients who reported No Vomiting in the overall phase in Cycle 1

  Overall phase (0-120 hours post initiation of MEC) in Cycle 1.

Secondary Outcomes (1)

• Number of Patients Who Reported Complete Response

  Overall phase (0-120 hours post initiation of MEC) in Cycle 1

Study Arms (2)

1

OTHER

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; Drug: Comparator: ondansetron; Drug: Comparator: dexamethasone; Drug: Comparator; Placebo (unspecified)

2

OTHER

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; Drug: Comparator: dexamethasone; Drug: Comparator: fosaprepitant dimeglumine; Drug: Comparator; Placebo (unspecified)

Interventions

aprepitant DRUG

aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.

Also known as: MK0869

1

Comparator: ondansetron DRUG

Ondansetron 8 mg capsule Three day treatment period.

Also known as: Zofran®

1; 2

Comparator: dexamethasone DRUG

dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.

Also known as: DEXAMETHASONE TABLETS USP

1; 2

Comparator: fosaprepitant dimeglumine DRUG

fosaprepitant dimeglumine 115 mg

Also known as: EMEND®

2

Comparator; Placebo (unspecified) DRUG

dexamethasone 12mg Pbo tablets.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (3)

• Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010 Apr;18(4):423-31. doi: 10.1007/s00520-009-0680-9. Epub 2009 Jul 1.

  PMID: 19568773 RESULT

• Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin. 2014 Sep;30(9):1875-81. doi: 10.1185/03007995.2014.925866. Epub 2014 Jun 12.

  PMID: 24911369 DERIVED

• Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11.

  PMID: 23062719 DERIVED

MeSH Terms

Conditions

Vomiting

Interventions

Aprepitant; Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: January 1, 2007
• Primary Completion: October 28, 2008
• Study Completion: November 19, 2008
• Last Updated: June 2, 2017
• Results First Posted: November 6, 2009

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share