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Palliative CancerPhase 2PRÊTNCT07882966

Prophylaxis for Emetogenic radioTherapy With Akynzeo

A Phase 2 study testing Akynzeo in people with Palliative Cancer, run by University Health Network, Toronto at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This phase II, prospective study evaluates whether prophylactic treatment with Akynzeo can reduce nausea and vomiting in patients receiving palliative radiotherapy in which the gastrointestinal GI tract is within the radiation field. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Cancer
What is being tested?
Akynzeo
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteCanada
Study dates
1 Nov 2026to 1 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Age ≥18 years old
  • Consent/registration on PERa study and selected for PRÊT study
  • Patients with a full list of analgesic and anti-nauseant medications used
  • Patients with the ability to complete the quality-of-life questionnaires
  • KPS ≥40
  • Patients who have planned for radiotherapy in PMCC to at least symptomatic site located in the body trunk between T10-Pelvis anatomical landmarks or if the stomach is within the field borders
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  • No planned changes in analgesic within 5 days before and after treatment
  • No planned cytotoxic chemotherapy, radiotherapy or surgery within 5 days before and 7 days after radiotherapy initiation. Oral molecularly targeted agents and immunotherapy are allowed to be continued without interruption or delay.
  • Able to swallow pills
  • The patient provided informed consent to participate in this study

Who cannot join

  • Patients with major mental or psychiatric impairments
  • Patients receiving brain radiation within 7 days of study intervention
  • Pregnant or breastfeeding (up to one month after the last dose) females.
  • Patients using CYP3A4 inducers within 4 weeks of Akynzeo treatment: Carbamazepine, Phenobarbital, Phenytoin, St. John's wort, Rifampicin, and Pioglitazone
  • Patients using CYP3A4 substrates concurrently with Akynzeo: pimozide, terfenadine, astemizole, or cisapride
  • Patients with hypersensitivity to netupitant/palonosetron drugs or to any ingredient in the formulation or component of the container.
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  • Patients who have or likely to develop prolongation of the QT interval. Risk factors include, but are not limited to, a personal or family history of QT prolongation (e.g., congenital long QT syndromes), electrolyte abnormalities or conditions that can lead to electrolyte abnormalities (e.g., eating disorders), cardiac disease (e.g., congestive heart failure, myocardial ischemia, conduction system disease), and bradycardia or bradyarrhythmia. Caution should also be observed in patients taking anti-arrhythmic medicinal products, other medicinal products that lead to QT prolongation or electrolyte abnormalities, or drugs that inhibit the metabolism of netupitant or palonosetron. Hypokalemia, hypocalcemia, and hypomagnesemia should be corrected prior to administration.
  • Patients with suspected or known severe hepatic impairment (Child-Pugh Score >9) and patients with a bilirubin >51.3 µmol/L, albumin <28 g/L and INR >2.3 from blood works done within 90 days.
  • Patients with suspected or known severe renal impairment (creatine clearance <30 mL/min per bloodwork done within 90 days), end-stage renal disease or on dialysis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

    Philip Wong, 416-946-4501, philip.wong4@uhn.ca

Other trials in Canada

About this study

This phase II, prospective study evaluates whether prophylactic treatment with Akynzeo can reduce nausea and vomiting in patients receiving palliative radiotherapy in which the gastrointestinal GI tract is within the radiation field. Patients undergoing emetogenic palliative radiotherapy will be enrolled and monitored for treatment-related nausea and vomiting. The study hypothesizes that Prophylactic use of Akynzeo will decrease the incidence and severity of these symptoms and improve patient comfort during radiotherapy.

Being tested
Akynzeo

What participants receive

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

  • AkynzeoDrug

    Akynzeo (1 Capsule PO: 300 mg netupitant/0.5 mg palonosetron) will be given once on the day of and prior to the first fraction of radiotherapy.

Study groups in NCT07882966
Study groupRoleWhat they receive
DrugExperimentalNot described
Receives: Drug: Akynzeo

What is being measured

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

  1. Incidence of symptomatic nausea and vomiting within 7 days of starting radiotherapy.

    Measured using the NCI Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the Common Terminology Criteria for Adverse Events (CTCAE) scales.

    Measured: 7 days

Secondary outcomes (4)

  1. Rate of complete control of nausea and vomiting, quality of life

    Proportion of patients achieving Complete Control of nausea and vomiting during the 5-day peak symptomatic period following the start of radiotherapy, as measured by the Functional Living Index - Emesis (FLIE) at the 1-week follow-up, visit.

    • Complete control: no increased episodes of nausea or vomiting with no increased use of antiemetic medication from baseline
    • Partial control: 1-2 increased episodes of nausea or vomiting with no increased use of antiemetic medication compared to baseline. Uncontrolled response: 3 or more increased episodes of nausea or vomiting, or increased use of anti-emetic medication from baseline
    • Overall control: includes complete and partial control

    Measured: 7 days

  2. Antiemetic Utilization: Drug Choice, Timing, and Duration

    Assessment of standard-of-care antiemetic prescribing patterns, including the antiemetic agent(s) prescribed, timing of administration relative to radiotherapy initiation, and duration of antiemetic therapy. This outcome evaluates variations in antiemetic management practices.

    Measured: 7 days

  3. Rate of interruption and discontinuation of RT.

    Measured: 7 days

  4. Akynzeo related adverse events per CTCAE V5

    Measured: 7 days

Timeline

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

  1. First posted20 Oct 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion1 Nov 2028 (estimated)
  4. Study completion1 Nov 2028 (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 2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07882966
Sponsor's protocol ID
25-5640
Other IDs
PWONG-01
Acronym
PRÊT
Status last verified
Oct 2026
First submitted
6 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Akynzeo in people with Palliative Cancer, run by University Health Network, Toronto at 1 site in Canada.

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 10 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of symptomatic nausea and vomiting within 7 days of starting radiotherapy. (time frame: 7 days). 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 NCT07882966.

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 20 Oct 2026.

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