NCT02484911

Brief Summary

The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
3 months until next milestone

Results Posted

Study results publicly available

March 30, 2017

Completed
Last Updated

March 30, 2017

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

June 22, 2015

Results QC Date

February 13, 2017

Last Update Submit

February 13, 2017

Conditions

Chemotherapy-induced Nausea and Vomiting

Keywords

chemotherapy nausea vomiting

Outcome Measures

Primary Outcomes (2)

  • Proportion of Participants Receiving HEC With Complete Response in Overall Phase

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

    0 to 120 hours

  • Proportion of Participants Receiving MEC With Complete Response in Overall Phase

    Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

    0 to 120 hours

Secondary Outcomes (10)

  • Proportion of Participants Receiving HEC With Complete Response in the Acute Phase

    0 to 24 hours

  • Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase

    24 to 120 hours

  • Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase

    0 to 120 hours

  • Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase

    0 to 24 hours

  • Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase

    24 to 120 hours

  • +5 more secondary outcomes

Study Arms (2)

Olanzapine regimen

EXPERIMENTAL

Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.

Drug: OlanzapineDrug: AprepitantDrug: PalonosetronDrug: Dexamethasone

Control regimen

OTHER

Aprepitant in combination with palonosetron and dexamethasone

Drug: AprepitantDrug: PalonosetronDrug: Dexamethasone

Interventions

OlanzapineDRUG

5mg,twice a day orally on day 1 to day 4

Olanzapine regimen
AprepitantDRUG

125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.

Control regimenOlanzapine regimen
PalonosetronDRUG

0.25mg IV 30-60min before chemotherapy on day 1

Control regimenOlanzapine regimen
DexamethasoneDRUG

6mg IV on day 1 ，3.75mg IV on day 2 to 4

Control regimenOlanzapine regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Histologically or cytologically confirmed malignant disease
  • Accept chemotherapy for the first time
  • Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin\>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide\>=1500mg/m2,adriamycin\>60mg/m2,epirubicin\>90mg/m2,dacarbazine，ifosfamide\>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin\>=300mg/m2,cyclophosphamide\>=600-1000mg/m2,adriamycin\>50mg/m2)
  • Written informed consent

You may not qualify if:

  • Pregnant or breast-feeding
  • Uncontrolled psychosis history
  • Inability or unwillingness to understand or cooperate with study procedures
  • Central nervous system tumors primary or secondary
  • Concurrent abdominal radiotherapy
  • History of uncontrolled diabetes mellitus
  • Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
  • Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
  • Pre-existing nausea or vomiting
  • Inadequate hematological function and abnormal liver and renal function.
  • History of sensitivity to olanzapine
  • Concurrent application of quinolone antibiotic therapy
  • Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
  • Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
  • Concurrent application of systemic corticosteroids
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150000, China

Location

Related Publications (10)

  • Andrews PL, Naylor RJ, Joss RA. Neuropharmacology of emesis and its relevance to anti-emetic therapy. Consensus and controversies. Support Care Cancer. 1998 May;6(3):197-203. doi: 10.1007/s005200050154.

    PMID: 9629870BACKGROUND

  • Matsuki N, Torii Y, Saito H. Effects of iron and deferoxamine on cisplatin-induced emesis: further evidence for the role of free radicals. Eur J Pharmacol. 1993 Dec 1;248(4):329-31. doi: 10.1016/0926-6917(93)90008-e.

    PMID: 8181539BACKGROUND

  • Tattersall FD, Rycroft W, Cumberbatch M, Mason G, Tye S, Williamson DJ, Hale JJ, Mills SG, Finke PE, MacCoss M, Sadowski S, Ber E, Cascieri M, Hill RG, MacIntyre DE, Hargreaves RJ. The novel NK1 receptor antagonist MK-0869 (L-754,030) and its water soluble phosphoryl prodrug, L-758,298, inhibit acute and delayed cisplatin-induced emesis in ferrets. Neuropharmacology. 2000 Feb 14;39(4):652-63. doi: 10.1016/s0028-3908(99)00172-0.

    PMID: 10728886BACKGROUND

  • Hesketh PJ, Van Belle S, Aapro M, Tattersall FD, Naylor RJ, Hargreaves R, Carides AD, Evans JK, Horgan KJ. Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists. Eur J Cancer. 2003 May;39(8):1074-80. doi: 10.1016/s0959-8049(02)00674-3.

    PMID: 12736106RESULT

  • Grunberg SM, Hesketh PJ. Control of chemotherapy-induced emesis. N Engl J Med. 1993 Dec 9;329(24):1790-6. doi: 10.1056/NEJM199312093292408.

    PMID: 8232489RESULT

  • Grunberg SM, Slusher B, Rugo HS. Emerging treatments in chemotherapy-induced nausea and vomiting. Clin Adv Hematol Oncol. 2013 Feb;11(2 Suppl 1):1-18; quiz 2 p following 18.

    PMID: 23598819RESULT

  • Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. Drugs. 2000 Sep;60(3):533-46. doi: 10.2165/00003495-200060030-00002.

    PMID: 11030465RESULT

  • Gao HF, Liang Y, Zhou NN, Zhang DS, Wu HY. Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy. Intern Med J. 2013 Jan;43(1):73-6. doi: 10.1111/j.1445-5994.2011.02637.x.

    PMID: 22141732RESULT

  • Tan L, Liu J, Liu X, Chen J, Yan Z, Yang H, Zhang D. Clinical research of Olanzapine for prevention of chemotherapy-induced nausea and vomiting. J Exp Clin Cancer Res. 2009 Sep 23;28(1):131. doi: 10.1186/1756-9966-28-131.

    PMID: 19775450RESULT

  • Navari RM, Gray SE, Kerr AC. Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a randomized phase III trial. J Support Oncol. 2011 Sep-Oct;9(5):188-95. doi: 10.1016/j.suponc.2011.05.002. Epub 2011 Sep 24.

    PMID: 22024310RESULT

Related Links

MeSH Terms

Conditions

Vomiting

Interventions

OlanzapineAprepitantPalonosetronDexamethasone

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorpholinesOxazinesHeterocyclic Compounds, 1-RingQuinuclidinesHeterocyclic Compounds, Bridged-RingIsoquinolinesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Dr.Zhang
Organization
First Affiliated Hospital of Harbin Medical University
daxinmay@126.com
85555068

Study Officials

  • Daxin Zhang, MD

    First Affiliated Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 30, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

March 30, 2017

Results First Posted

March 30, 2017

Record last verified: 2016-06

Locations

CN(1)