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Chemotherapy-induced Nausea and Vomiting (CINV)Phase 3NCT00952341

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

A Phase 3 study testing aprepitant, dexamethasone and granisetron in people with Chemotherapy-induced Nausea and Vomiting (CINV), run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
aprepitant, dexamethasone and granisetron
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
No sites listed yet
Study dates
25 Aug 2009to 5 May 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

  • 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

About this study

Official 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

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

Being tested
aprepitant, Comparator: Placebo to aprepitant, dexamethasone, granisetron
Keywords
CINV
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aprepitantDrug

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

  • Comparator: Placebo to aprepitantDrug

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

  • dexamethasoneDrug

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

  • granisetronDrug

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

  • dexamethasoneDrug

    Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg

Study groups in NCT00952341
Study groupRoleWhat they receive
Aprepitant (MK-0869)ExperimentalNot described
Receives: Drug: aprepitant; Drug: granisetron; Drug: dexamethasone
Standard TherapyPlacebo comparatorNot described
Receives: Drug: Comparator: Placebo to aprepitant; Drug: dexamethasone; Drug: granisetron

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

    Measured: 0 to 120 hours

Secondary outcomes (7)

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

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

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

    Measured: 0 to 24 hours

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

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

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

    Measured: 25 to 120 hours

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

    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).

    Measured: 0 to 120 hours

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

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

    Measured: 0 to 24 hours

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

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

    Measured: 25 to 120 hours

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

    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).

    Measured: 0 to 120 hours

  7. Time to First Vomiting Episode in Cycle 1

    Time from administration of chemotherapy to first vomiting episode.

    Measured: 0 to 120 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2009 (estimated)
  2. Study start25 Aug 2009
  3. Primary completion4 Apr 2010
  4. Study completion5 May 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00952341
Sponsor's protocol ID
0869-169
Other IDs
2009_626
Status last verified
May 2017
First submitted
31 Jul 2009
Last updated
2 Jun 2017
Data monitoring committee
No
Individual data sharing
Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

  • Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26.

    PubMed 24276953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing aprepitant, dexamethasone and granisetron in people with Chemotherapy-induced Nausea and Vomiting (CINV), run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00952341, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.

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