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OpenTrials
Completed

NCT Number: NCT00952341

Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cycle 1:

  • Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
  • Patient has a predicted life expectancy of at least 3 months
  • Patient is not pregnant

Cycle 2 (optional):

  • Participation in the study during the next cycle of chemotherapy is considered

appropriate by the investigator and will not pose unwarranted risk to the patient.

  • Satisfactory completion of the preceding cycle of chemotherapy and related

study procedures.

  • Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new

dose is still no less than 70 mg/m^2.

Exclusion criteria

Cycles 1 & 2:

  • Patient will receive stem cell therapy in conjunction with cisplatin
  • Patient has an active infection or any uncontrolled disease (e.g. diabetes)
  • Patient will receive multiple-day chemotherapy with cisplatin
  • Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
  • Patient has vomited within 24 hours prior to cisplatin infusion
  • Patient received or will receive radiation therapy to the abdomen

Treatment and study plan

Aprepitant

Drug

Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg

Comparator: Placebo to aprepitant

Drug

Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg

Dexamethasone

Drug

Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg

Granisetron

Drug

Day 1: IV granisetron 3 mg prior to administration of cisplatin

Primary outcomes

  1. Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1

    Time frame: 0 to 120 hours

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

Secondary outcomes

  1. Proportion of Participants With Complete Response in the Acute Phase of Cycle 1

    Time frame: 0 to 24 hours

    Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

  2. Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1

    Time frame: 25 to 120 hours

    Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.

    Complete response was defined as no vomiting with no rescue therapy.

  3. Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1

    Time frame: 0 to 120 hours

    Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

    No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

  4. Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1

    Time frame: 0 to 24 hours

    Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.

  5. Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1

    Time frame: 25 to 120 hours

    Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy

  6. Proportion of Participants With No Impact on Daily Life in Cycle 1

    Time frame: 0 to 120 hours

    The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).

  7. Time to First Vomiting Episode in Cycle 1

    Time frame: 0 to 120 hours

    Time from administration of chemotherapy to first vomiting episode.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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