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

NCT ID: NCT00337727

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2008-11-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

aprepitant

Intervention Type: DRUG

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

Comparator: ondansetron

Intervention Type: DRUG

Ondansetron 8 mg capsule Three day treatment period.

Comparator: dexamethasone

Intervention Type: DRUG

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

Comparator; Placebo (unspecified)

Intervention Type: DRUG

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.

Group Type: OTHER

Comparator: ondansetron

Intervention Type: DRUG

Ondansetron 8 mg capsule Three day treatment period.

Comparator: dexamethasone

Intervention Type: DRUG

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

Comparator: fosaprepitant dimeglumine

Intervention Type: DRUG

fosaprepitant dimeglumine 115 mg

Comparator; Placebo (unspecified)

Intervention Type: DRUG

Aprepitant 80 mg \& 125 mg Pbo capsules.

Interventions

aprepitant

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

Intervention Type: DRUG

Comparator: ondansetron

Ondansetron 8 mg capsule Three day treatment period.

Intervention Type: DRUG

Comparator: dexamethasone

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

Intervention Type: DRUG

Comparator: fosaprepitant dimeglumine

fosaprepitant dimeglumine 115 mg

Intervention Type: DRUG

Comparator; Placebo (unspecified)

dexamethasone 12mg Pbo tablets.

Intervention Type: DRUG

Comparator; Placebo (unspecified)

Aprepitant 80 mg \& 125 mg Pbo capsules.

Intervention Type: DRUG

Other Intervention Names

MK0869; Zofran®; DEXAMETHASONE TABLETS USP; EMEND®

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 19568773 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24911369 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23062719 (View on PubMed)

Other Identifiers

2006_016

Identifier Type: OTHER

Identifier Source: secondary_id

0869-130

Identifier Type: -

Identifier Source: org_study_id