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Chemotherapy Induced Nausea VomitingPhase 2CINVNCT03008213

Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV

A Phase 2 study testing Netupitant and Palonosetron in people with Chemotherapy Induced Nausea Vomiting, run by Joseph Ma.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy Induced Nausea Vomiting
What is being tested?
Netupitant and Palonosetron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
No sites listed yet
Study dates
Jan 2017to 22 Jan 2018
Phase
Phase 2
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

  • Adults greater than or equal to 18 years old.
  • Must have a histologically confirmed cancer diagnosis.
  • Must have refractory CINV defined as nausea and/or vomiting that occurs after the first cycle of chemotherapy despite guideline-based prophylaxis and after first-line rescue medication with either a dopamine receptor antagonist, steroid, and/or benzodiazepine.
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
  • Life expectancy greater than 3 months.
  • Corrected serum calcium level less than or equal to 10.5 mg/dL.
Show all 11Show fewer
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 14 days following completion of therapy.
  • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or ii) Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time in the preceding 12 consecutive months)
  • Women of child-bearing potential must have a negative pregnancy test prior to initiating study treatment.
  • Ability to understand and willingness to sign a written informed consent.

Who cannot join

  • Patients with QTc interval greater than 450 ms.
  • Patients with a known hypersensitivity reaction to 5-HT3 receptor antagonists or NK1 receptor antagonists.
  • Patients who have taken any medication classified as a strong CYP3A4 inducer within one week of Study Day 1 or 5 halflives (whichever is longer) or use of a strong or moderate CYP3A4 inhibitor within one week of Study Day 1 or 5 halflives (whichever is longer) (see Appendix 2).
  • Patients with severe hepatic impairment as defined as AST/ALT greater than three times the upper limit of normal, total bilirubin greater than 3 mg/dL, and/or Child-Pugh score >9.
  • Patients with end-stage renal disease defined as creatinine clearance of <15mL/min and/or diagnosed with Stage 5 chronic kidney disease.
  • Pregnant or lactating females are excluded from enrollment on this trial.
  • Patients unable to swallow oral medications. Any other condition that, in the opinion of the investigator, may impact the absorption of oral medications.

About this study

Official title: Fixed Dose Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory Chemotherapy-Induced Nausea and Vomiting

Prevention and control of Chemotherapy-Induced Nausea and Vomiting (CINV) are most important in treatment of cancer patients. CINV is one of the most distressing severe side effects of cancer treatment and can have a significant impact on a patient's quality of life. The chemotherapy agents that cause the worst degree of nausea and vomiting are categorized into two groups: moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC). Nausea and vomiting that occurs within the first day of the administration of chemotherapy agents is considered acute CINV, while nausea and vomiting following 24 hours of the administration of chemotherapy agents is considered delayed CINV. Refractory CINV occurs when patients develop CINV during subsequent cycles of chemotherapy when drugs preventing vomiting and nausea (antiemetic prophylaxis) has not been successful in controlling CINV in earlier cycles. The purpose of this study is to assess the efficacy of Akynzeo in the treatment of refractory CINV

Read the detailed description

This is a Phase II, single-center, single-arm, open-label, feasibility trial using a fixed dose combination of netupitant and palonosetron (Akynzeo®) in the treatment of refractory CINV. The primary aim of this study is feasibility, defined as 70% completion rate of all study procedures over 7 days.

Eligible subjects will be identified in weekly palliative care patient triage meetings. Patients who are 18 years of age or older, have histologically confirmed cancer, and confirmed refractory CINV will be eligible. After obtaining written informed consent and verifying that the study subject meets all eligibility criteria, the subject will be enrolled in the study through the University California San Diego (UCSD) Moores Cancer Center Clinical Trials Office. Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1. Study drug may be taken with or without food. Subjects will complete a study drug diary to document date and time of Akynzeo® administration. On Study Day 1, the study coordinator will educate the subject on how to complete the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool, and Functional Living Index Emesis (FLIE) scale, and medication diary and each of these documents will be completed for that day. An adequate number of copies of each subject questionnaire and diary will be provided to the subject on Study Day 1 for completion at home during the post-treatment observation portion of the study (Study Days 2-7) as needed.

Being tested
Netupitant and Palonosetron

What participants receive

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

  • Netupitant and PalonosetronDrug

    Also called Akynzeo

    300 mg of netupitant and 0.5 mg of palonosetron

Study groups in NCT03008213
Study groupRoleWhat they receive
Netupitant and PalonosetronExperimentalSubjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.
Receives: Drug: Netupitant and Palonosetron

What is being measured

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

  1. Number of Participants Completed All Study Procedures Over Seven Days

    The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.

    For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.

    Measured: Through study completion, 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 posted2 Jan 2017 (estimated)
  2. Study startJan 2017
  3. Primary completion22 Jan 2018
  4. Study completion22 Jan 2018

Why it stopped: PI is leaving UCSD

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03008213
Sponsor's protocol ID
UCSD
Acronym
CINV
Status last verified
Dec 2019
First submitted
14 Dec 2016
Last updated
9 Dec 2019
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Netupitant and Palonosetron in people with Chemotherapy Induced Nausea Vomiting, run by Joseph Ma.

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: stopped early, as of the sponsor's last update on 9 Dec 2019. 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. 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?

Yes. Results are posted in the registry (first posted 9 May 2019). 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?

Number of Participants Completed All Study Procedures Over Seven Days (time frame: Through study completion, 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 NCT03008213.

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 9 Dec 2019.

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