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Netupitant and Palonosetron (AKYNZEO) for Chronic Nausea and Vomiting in Cancer Patients

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ClinicalTrials.gov Identifier: NCT03040726
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
Helsinn Healthcare SA
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if netupitant/palonosetron can help to decrease chronic nausea and vomiting in patients with cancer. The safety of the study drug will also be studied.

Some participants will receive the study drug and some will receive a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

This is an investigational study. Netupitant/palonosetron is FDA approved and commercially available to help prevent short-term nausea and vomiting. Giving it to patients with chronic nausea and vomiting is investigational.

The study doctor can explain how the study drug is designed to work.

Up to 42 participants will be enrolled in this study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
In Situ Neoplasm Malignant Neoplasms Nausea and Vomiting, Chronic Drug: Netupitant / Palonosetron Other: Placebo Behavioral: Symptom Questionnaires Behavioral: Patient Diary Phase 2 Phase 3

Detailed Description:

Study Drug Administration:

If you are still eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 2 groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have a 2 in 3 chance of being assigned to the netupitant/palonosetron group.

You will take 1 capsule of netupitant/palonosetron/placebo by mouth on Days 1, 6, and 11. You will report the time you take these doses to the study staff.

For the Day 1 dose, you will not know if you are receiving the study drug or the placebo. For the Days 6 and 11 doses, neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

You will take the Day 1 dose in the clinic or at home. The Days 6 and 11 doses may be mailed to you separately and should not be taken until you have instructed to by the study staff.

You will be given a patient diary to keep track of your daily nausea, vomiting, and rescue nausea medication on Days 1-15. You should complete it at the end of each day before you go to sleep.

Length of Study:

You may take the study drug/placebo until Day 11. You will no longer be able to take the study drug/placebo if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over after your last visit/call. There is also an optional 10-day extension described below.

Study Visits/Calls:

On Day 4 (+/- 1 day), the research staff will call you to ask about your level of nausea in the past 24 hours, your average level of nausea over the past 5 days, and your feeling of nausea and vomiting in the last 12 hours. This is information you would have recorded in your patient diary. This call should last about 10 minutes.

On Day 10 (+/- 2 days), the research staff will call you to ask about your average level of nausea over the past 5 days, your level of nausea and vomiting in the past 5 days, your symptoms in the past 24 hours, and any side effects from taking the study drug or placebo. This call should last about 15 minutes.

On Day 15 (+/- 2 days), you will complete questionnaires about your average level of nausea over the past 5 days, your nausea/vomiting symptoms, side effects, your opinion on whether you received the study drug or placebo, and your opinion about taking part in the study. These questionnaires should take about 20 minutes to complete. If you are unable to return to the clinic, the research staff will call you to ask you to answer these questions by phone.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Fixed-Dose Netupitant and Palonosetron for Chronic Nausea and Vomiting in Cancer Patients
Actual Study Start Date : May 3, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Netupitant + Palonosetron (NEPA) Group

Symptom questionnaires completed at baseline and at Day 15.

For the Day 1 dose, participant will not know if they are receiving the study drug or the placebo.

Participants take NEPA orally on Day 6 and on Day 11 of the double-blind treatment period, and on Day 16 and on Day 21 of the open-label extension phase.

Participants keep a patient diary to keep track of nausea, vomiting, and doses 1 time a day on Days 1-15.

Drug: Netupitant / Palonosetron

Netupitant/Palonosetron (NEPA) by mouth on Day 6 and on Day 11 of the double-blind treatment period, and on Day 16 and on Day 21 of the open-label extension phase.

NEPA is a fixed dosed capsule consisting of 300 mg netupitant and 0.5 mg palonosetron.

Other Name: Akynzeo

Other: Placebo
Participants take placebo orally on Day 6 and on Day 11 of the double-blind treatment period, and on Day 16 and on Day 21 of the open-label extension phase.
Other Name: Sugar pill

Behavioral: Symptom Questionnaires
Symptom questionnaires completed at baseline and at Day 15. These questionnaires should take about 20 minutes to complete.
Other Name: Surveys

Behavioral: Patient Diary
Participants keep a patient diary to keep track of nausea, vomiting, and doses 1 time a day on Days 1-15. Participants should complete it at the end of each day before you go to sleep.

Placebo Comparator: Placebo Group

Symptom questionnaires completed at baseline and at Day 15.

For the Day 1 dose, participant will not know if they are receiving the study drug or the placebo.

Participants take placebo orally on Day 6 and on Day 11 of the double-blind treatment period, and on Day 16 and on Day 21 of the open-label extension phase.

Participants keep a patient diary to keep track of nausea, vomiting, and doses 1 time a day on Days 1-15.

Drug: Netupitant / Palonosetron

Netupitant/Palonosetron (NEPA) by mouth on Day 6 and on Day 11 of the double-blind treatment period, and on Day 16 and on Day 21 of the open-label extension phase.

NEPA is a fixed dosed capsule consisting of 300 mg netupitant and 0.5 mg palonosetron.

Other Name: Akynzeo

Other: Placebo
Participants take placebo orally on Day 6 and on Day 11 of the double-blind treatment period, and on Day 16 and on Day 21 of the open-label extension phase.
Other Name: Sugar pill

Behavioral: Symptom Questionnaires
Symptom questionnaires completed at baseline and at Day 15. These questionnaires should take about 20 minutes to complete.
Other Name: Surveys

Behavioral: Patient Diary
Participants keep a patient diary to keep track of nausea, vomiting, and doses 1 time a day on Days 1-15. Participants should complete it at the end of each day before you go to sleep.




Primary Outcome Measures :
  1. Change in Nausea Numeric Rating Scale [NRS] of Fixed Dose Netupitant and Palonosetron (NEPA) for Chronic Nausea in Cancer Patients [ Time Frame: Baseline and between day 5 and day 15 ]
    Participants complete a diary daily from time of enrollment through the end of study documenting the average intensity of nausea over the preceding 24 h using a 0-10 NRS (where 0=no nausea and 10=worst possible. The minimal clinically important difference is 1 point.


Secondary Outcome Measures :
  1. Personalized Nausea Response of Fixed Dose Netupitant and Palonosetron (NEPA) for Chronic Nausea in Cancer Patients [ Time Frame: Baseline and between day 5 and day 15 ]

    Personalized nausea response defined as nausea Nausea Numeric Rating Scale (NRS) ≤ personalized nausea goal.

    Personalized nausea goal assessed by asking "At what level of intensity would you feel comfortable? 0-10 where 0=no nausea and 10=worst possible".




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of cancer with evidence of active disease
  2. Chronic nausea over the past 4 weeks
  3. Average nausea numeric rating scale >/=4/10 over past 24 hours at screening
  4. Outpatient at MD Anderson Cancer Center
  5. Karnofsky performance status >/=50%
  6. Age 18 or older
  7. Able to complete study assessments, including keeping a daily diary

Exclusion Criteria:

  1. Delirium (i.e. Memorial Delirium Rating Scale >13)
  2. Clinical evidence of bowel obstruction at the time of study enrollment
  3. Expected to use other 5HT3 antagonists or NK1 antagonists during the study
  4. Continuation of over-the-counter therapies for nausea and/or vomiting during the study
  5. On cytotoxic chemotherapy in the high/moderate/low emetogenic risk categories or oral antineoplastic agents in the high or moderate emetogenic risk categories according to the latest NCCN guideline within 2 weeks of study enrollment
  6. On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe, carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, glucocorticoids, modafinil, oxcarbazepine, phenobarbital, pioglitazone, rifabutin, St. John's wort, troglitazone)
  7. On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus)
  8. On scheduled strong or moderate CYP3A4 inhibitors (boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole; amprenavir, aprepitant, atazanavir, ciprofloxacin, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil) within one week of study enrollment
  9. Unwilling to provide informed consent
  10. Severe renal impairment (calculated Creatinine clearance <=29 cc/min)
  11. Severe liver impairment (Child-Pugh Score >9)
  12. Females who are pregnant, lactating, or intend to become pregnant during the participation of the study; childbearing age women who are not on birth control. Positive pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and no history of menses within the last 12 months. Pregnancy test to be performed on the day of enrollment. In cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy and the non-pregnant status is confirmed by a Gynecologic examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040726


Contacts
Contact: David Hui, MD 713-792-6085 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Helsinn Healthcare SA
Investigators
Principal Investigator: David Hui, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03040726     History of Changes
Other Study ID Numbers: 2016-0843
NCI-2017-00599 ( Registry Identifier: NCI CTRP )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Chronic nausea and vomiting
In situ neoplasm
Malignant neoplasms of independent (primary) multiple sites
Symptoms and signs involving the digestive system and abdomen
Netupitant/Palonosetron
NEPA
Placebo
Sugar pill
Symptom questionnaires
Surveys
Pill diary
Akynzeo

Additional relevant MeSH terms:
Vomiting
Neoplasms
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs