OncologyPhase 4NCT03831633
Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients
A Phase 4 study testing Akynzeo in people with Oncology, run by VIFORFRANCE at 1 site in France.
Trial summary
This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- What is being tested?
- Akynzeo
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2018to 31 Jul 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, Age ≥ 18 years
- Have a histological or cytological confirmed solid tumor malignancy
- Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor
- Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's
- Naïve of CT
- ECOG performance up to 2
- Able to read, understand and follow the study procedures
- Patient with Health insurance
Who cannot join
- Pregnancy and breastfeeding women;
- Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;
- Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.
This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting
- Conditions
- Oncology
- Being tested
- Akynzeo, Standard of Care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AkynzeoDrug
1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron).
- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
Standard of CareDrug
- oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3)
- IV ondansetron 8 mg on Day 1
- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
| Study group | Role | What they receive |
|---|---|---|
| AKYNZEO | Experimental | Not described Receives: Drug: Akynzeo |
| Standard of Care | Active comparator | Not described Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-emetic response
Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen
Measured: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start19 Sep 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIFORFRANCE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831633
- Sponsor's protocol ID
- PRAKYFRA-01
- Status last verified
- Feb 2019
- First submitted
- 2 Feb 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.
- ClinicalTrials.gov ID
- NCT03831633
- Acronym / sponsor ID
- PRAKYFRA-01
- Conditions
- Oncology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- VIFORFRANCEIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKYNZEO | Experimental | Drug: Akynzeo |
| Standard of Care | Active comparator | Drug: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, Age ≥ 18 years
- Have a histological or cytological confirmed solid tumor malignancy
- Patient scheduled to receive their first course of anthracycline cyclophosphamide (AC) based chemotherapy regimen or Moderately Emetogenic Chemotherapy for the treatment of solid malignant tumor
- Patient scheduled to receive CINV prevention with AKYNZEO® or Standard of Care according to the summary of product characteristics based on the judgement of their investigator's
- Naïve of CT
Key exclusion criteria (3 listed)
- Pregnancy and breastfeeding women;
- Hypersensitivity to active substances, excipients or other ingredients of Akynzeo® or Emend®;
- Protected patients: majors under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Akynzeo1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron). - Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4 | Drug | AKYNZEO |
| Standard of Care* oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3) * IV ondansetron 8 mg on Day 1 * Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4 | Drug | Standard of Care |
Primary outcome
Anti-emetic response
Time frame: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Akynzeo in people with Oncology, run by VIFORFRANCE at 1 site in France.
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 8 inclusion and 3 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 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Stéphane OUARY (+33662755802 ext. 5802, stephane.ouary@capionis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-emetic response (time frame: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2019.