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Solid Tumor Patients Receiving High Emetic Risk Multi-day ChemotherapyPhase 3OFFERNCT04536558

Olanzapine Plus Fosaprepitant Standard Antiemetic Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Receiving High Emetic Risk Multi-day Chemotherapy: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study

A Phase 3 study testing olanzapine plus fosaprepitant-based triple regimen in people with Solid Tumor Patients Receiving High Emetic Risk Multi-day Chemotherapy, run by Sun Yat-sen University at 18 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a multicenter, randomized, controlled, double-blind, phase III study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
olanzapine plus fosaprepitant-based triple regimen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
352 participants
Where
18 sitesChina
Study dates
1 Oct 2020to 30 Mar 2021
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged ≥ 18 and ≤ 75 years old;
  • Patients were diagnosed with histologically or cytology confirmed solid malignant tumors;
  • Patients have a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2;
  • Patients were predicted life expectancy of ≥ 3 months;
  • Patients who were scheduled for 3 days of cisplatin based chemotherapy.

Who cannot join

  • Patients were mentally disable or suffered from emotional disorders;
  • Patients were current illicit drug use, including alcohol abuse;
  • Patients scheduled administration of stem cell rescue therapy during cisplatin chemotherapy;
  • Patients have participated in other clinical trials in the past 4 weeks;
  • Patients were treated with chemotherapy including ordinary paclitaxel(using castor oil as a solvent);
  • Patients with active infections (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignant tumors, and the researchers believe that it may confound the results of the study or expose patients receiving treatment with the study drug at unnecessary risk;
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  • Patients have any disease that the researcher believes may confound the results of the study or expose the patient to unnecessary risk；
  • Patients were treated with moderate or highly emetogenic chemotherapy within 6 days prior to the initial of cisplatin infusion and/or 6 days after cisplatin infusion;
  • Patients were scheduled to receive radiation therapy to the abdomen or pelvis within a week of treatment;
  • Absolute neutrophil count<1,500 cells/ L, white blood cell count<3,000 cells/ L, platelet count<100,000 cells/ L, aspartate aminotransferase and alanine aminotransferase>2.5 upper limit of normal (ULN), bilirubin > 1.5 ULN, and creatinine > 1.5 ULN;
  • Patients were pregnant or breastfeeding;
  • Patients had suffered from vomiting or nausea in the 24 hours before treatment;
  • Patients were known to be at risk for narrow angle glaucoma；
  • Patients who are taking or have used CYP3A4 inducers within 30 days before the first day of treatment, which will affect the efficacy of the treatment drugs according to the researcher's evaluation, can not be enrolled;
  • Patients who are taking or have used CYP3A4 substrates and inhibitors within 7 days before the first day of treatment will significantly increase the treatment drug-related adverse events according to the researcher's evaluation, can not be enrolled;
  • Within 48 hours before the first day of treatment, patients used the following antiemetic agents: 5-hydroxytryptamine 3 receptor antagonists (such as ondansetron), phenothiazines (such as prochlorperazine), benzophenones (such as haloperidol), benzamide (such as metoclopramide), domperidone, cannabinoids, herbs with potential antiemetic effects, scopolamine, and cyclizine, etc;
  • Patients began to receive benzodiazepines or opioids within 48 hours prior to the first day of the study (except for triazolam, temazepam or midazolam single dose daily);
  • Patients had symptomatic primary or metastatic central nervous system malignancies;
  • Patients had concomitant diseases that could not take dexamethasone for 5 days, such as systemic fungal infection or uncontrolled diabetes mellitus;
  • Patients were not allowed to receive any dose of systemic glucocorticoid therapy within 72 hours before the first day except those prescribed in the protocol; however, local and inhaled corticosteroids were allowed;
  • Patients had a history of hypersensitivity to fosaprepitant meglumine, olanzapine, ondansetron or dexamethasone；
  • Patients had been treated with neurokinin-1 receptor antagonist in the past;

Trial locations and contacts

18 sites in 1 country.

Li Zhang contact

+86 20-87342288

zhangli@sysucc.org.cn

18 sites in 1 country

China18 sites

  • Beijing Cancer Hospital

    Beijing

    Jian Fang

    Jian Fang

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Jianchun Duan

    Jianchun Duan

  • Hunan Cancer Hospital

    Changsha

    Lin Wu

    Lin Wu

  • Sichuan Cancer Hospital& Institute

    Chengdoucun

    Wenxiu Yao

    Wenxiu Yao

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Xiaopin Chen

    Xiaopin Chen

  • Sun Yat-sen University Cancer Center

    Guangdong

    Li Zhang

    Li Zhang

  • Harbin Medical University Cancer Hospital

    Haerbin

    Li Cai

    Li Cai

  • Anhui Provincial Cancer Hospital

    Hefei

    Changlu Hu

    Changlu Hu

  • Yunnan Cancer Hospital

    Kunming

    Runxiang Yang

    Runxiang Yang

  • Jiangxi Cancer Hospital

    Nanchang

    Yinglan Chen

    Yinglan Chen

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning

    Qitao Yu

    Qitao Yu

  • Ningbo Medical Center Lihuili Hospital

    Ningbo

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

    Shanghai

    Daliu Min

    Daliu Min

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Tao Sun

    Tao Sun

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang

    Junfeng Liu

    Junfeng Liu

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Kai Chen

    Kai Chen

  • Tianjin Medical University General Hospital

    Tianjin

    Diansheng Zhong

    Diansheng Zhong

  • Henan Cancer Hospital

    Zhengzhou

    Yanqiu Zhao

    Yanqiu Zhao

Other trials in China

About this study

Official title: Olanzapine Plus Fosaprepitant Standard Antiemetic Therapy in the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients Receiving High Emetic Risk Multi-day Chemotherapy: a Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study（OFFER）

This is a multicenter, randomized, controlled, double-blind, phase III study.

Read the detailed description

This is a multicenter, randomized, controlled, double-blind, phase III study assessing the efficacy and safety of Olanzapine plus fosaprepitant plus ondansetron and dexamethasone versus fosaprepitant plus ondansetron and dexamethasone in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high emetic risk multi-day chemotherapy. Eligible patients will be randomized to receive either olanzapine plus fosaprepitant standard antiemetic therapy or fosaprepitant standard antiemetic therapy in a 1:1 ratio.

Being tested
olanzapine plus fosaprepitant-based triple regimen, placebo plus fosaprepitant-based triple regimen

What participants receive

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

  • olanzapine plus fosaprepitant-based triple regimenDrug

    olanzapine 5mg p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.

  • placebo plus fosaprepitant-based triple regimenDrug

    placebo p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.

Study groups in NCT04536558
Study groupRoleWhat they receive
olanzapine plus fosaprepitant-based triple regimenExperimentalOlanzapine（5mg p.o. d1-d5）plus fosaprepitant（150mg i.v. d1-d3） plus ondansetron（8mg i.v. d1-d3）and dexamethasone（6mg p.o. d1-d5） before undergoing chemotherapy.
Receives: Drug: olanzapine plus fosaprepitant-based triple regimen
Placebo plus fosaprepitant-based triple regimenPlacebo comparatorPlacebo plus fosaprepitant（150mg i.v. d1-d3） plus ondansetron（8mg i.v. d1-d3）and dexamethasone（6mg p.o. d1-d5） before undergoing chemotherapy.
Receives: Drug: placebo plus fosaprepitant-based triple regimen

What is being measured

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

  1. Complete response (CR) during overall phase

    To compare olanzapine plus fosaprepitant regimen with placebo plus fosaprepitant regimen with respect to efficacy; complete response (CR) defined as no vomiting and no use of rescue therapy during overall phase (day 1 to day 8） after highly emetogenic chemotherapy initiation)

    Measured: Day 1 to day 8 after highly emetogenic chemotherapy initiation

Secondary outcomes (9)

  1. Complete response (CR) during acute phase

    Measured: Day 1 to day 3 days after highly emetogenic chemotherapy initiation

  2. Complete response (CR) during delayed phase

    Measured: Day 4 to day 8 after highly emetogenic chemotherapy initiation

  3. No significant nausea during overall phase using questionnaire

    Measured: Day 1 to day 8 after highly emetogenic chemotherapy initiation

  4. No significant nausea during acute phase using questionnaire

    Measured: Day 1 to day 3 after highly emetogenic chemotherapy initiation

  5. No significant nausea during delayed phase using questionnaire

    Measured: Day 4 to day 8 after highly emetogenic chemotherapy initiation

  6. To compare quality of life using the functional living index-emesis questionnaire

    Measured: From baseline to day 8 after highly emetogenic chemotherapy initiation

  7. To compare olanzapine plus fosaprepitant regimen with placebo plus fosaprepitant regimen in terms of the number of days to first emetic episode.

    Measured: Day 1 to day 8 after highly emetogenic chemotherapy initiation

  8. To compare the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: From baseline to day 8 after highly emetogenic chemotherapy initiation

  9. To compare the change of score using Hospital Anxiety and Depression Scale

    Hospital Anxiety and Depression Scale includes two subscales: anxiety and depression, with 7 items for anxiety (a) and depression (d) respectively. Each item is divided into four grades of 0-3. The higher the score is, the more serious the anxiety and depression are.

    Measured: From baseline to day 8 after highly emetogenic chemotherapy initiation

Timeline

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

  1. First posted2 Sep 2020
  2. Study start1 Oct 2020 (estimated)
  3. Primary completion1 Feb 2021 (estimated)
  4. Study completion30 Mar 2021 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536558
Sponsor's protocol ID
HS-TN-001
Acronym
OFFER
Status last verified
Aug 2020
First submitted
25 Aug 2020
Last updated
2 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Y, Yang Y, Gao F, Hu C, Zhong D, Lu M, Yuan Z, Zhao J, Miao J, Li Y, Zhu J, Wang C, Han J, Zhao Y, Huang Y, Zhang L. A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study). EClinicalMedicine. 2022 Dec 15;55:101771. doi: 10.1016/j.eclinm.2022.101771. eCollection 2023 Jan.

    PubMed 36712888

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing olanzapine plus fosaprepitant-based triple regimen in people with Solid Tumor Patients Receiving High Emetic Risk Multi-day Chemotherapy, run by Sun Yat-sen University at 18 sites in China.

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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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

Contact Li Zhang (+86 20-87342288, zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) during overall phase (time frame: Day 1 to day 8 after highly emetogenic chemotherapy initiation). 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 NCT04536558, 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 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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