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Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040726
Recruitment Status : Active, not recruiting
First Posted : February 2, 2017
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Helsinn Healthcare SA
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Nausea Vomiting Drug: Netupitant Drug: Palonosetron Drug: Palonosetron Hydrochloride Other: Placebo Other: Questionnaire Administration Phase 2 Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the efficacy (i.e. change in nausea numeric rating scale [NRS] from baseline between day 5-15) of fixed dose netupitant and palonosetron hydrochloride (palonosetron) (NEPA) for chronic nausea in cancer patients.

SECONDARY OBJECTIVES:

I. To assess the secondary outcomes (e.g. proportion of patients who achieved their personalized nausea goal, antiemetic use, nausea episodes duration/frequency) for NEPA versus (vs.) placebo.

II. To assess the adverse effects associated with NEPA and placebo.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive placebo PO on days 1, 6, and 11.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 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 : November 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (netupitant, palonosetron hydrochloride)
Patients receive netupitant orally (PO) and palonosetron hydrochloride PO on days 1, 6, and 11 in the absence of disease progression or unacceptable toxicity.
Drug: Netupitant
Given PO
Other Names:
  • CID6451149
  • D05152
  • RO 67-3189/000

Drug: Palonosetron
Given PO

Drug: Palonosetron Hydrochloride
Given PO
Other Names:
  • Aloxi
  • RS 25259-197

Other: Questionnaire Administration
Ancillary studies

Placebo Comparator: Group II (placebo)
Patients receive placebo PO on days 1, 6, and 11.
Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in nausea numeric rating scale [ Time Frame: Day 5-15 ]
    Descriptive statistics, including mean, standard deviation, 95% confidence intervals, median, range, frequency and percentage will be summarized. Will use a mixed model to examine the change in nausea overtime in both the netupitant and palonosetron hydrochloride arm and placebo arm. General linear model may be considered to examine the effect of potential important factors on nausea numeric rating scale.


Secondary Outcome Measures :
  1. Proportion of patients who achieved their personalized nausea goal [ Time Frame: Up to day 15 ]
    Descriptive statistics, including mean, standard deviation, 95% confidence intervals, median, range, frequency and percentage will be summarized.

  2. Antiemetic use [ Time Frame: Up to day 15 ]
    Descriptive statistics, including mean, standard deviation, 95% confidence intervals, median, range, frequency and percentage will be summarized.

  3. Nausea episodes duration/frequency [ Time Frame: Up to day 15 ]
    Descriptive statistics, including mean, standard deviation, 95% confidence intervals, median, range, frequency and percentage will be summarized.

  4. Incidence of adverse events [ Time Frame: Up to day 15 ]
    Will be assessed by Common Terminology Criteria for Adverse Events. Will be collected and frequency will be summarized. Chi-squared test or Fisher's exact test, whichever the most appropriate, will be used to test for association between categorical variables, such as Common Terminology Criteria for Adverse Events adverse effects, between netupitant and palonosetron hydrochloride and placebo.

  5. Global assessment [ Time Frame: Up to day 15 ]
    Chi-squared test or Fisher's exact test, whichever the most appropriate, will be used to test for association between categorical variables, such as global assessment, between netupitant and palonosetron hydrochloride and placebo.

  6. Blinding [ Time Frame: Up to day 15 ]
    Chi-squared test or Fisher's exact test, whichever the most appropriate, will be used to test for association between categorical variables, such as blinding, between netupitant and palonosetron hydrochloride and placebo.

  7. Edmonton Symptom Assessment System [ Time Frame: Up to day 15 ]
    Wilcoxon rank sum test or Kruskal-Wallis test will be used to test for difference of continuous variables, such as Edmonton Symptom Assessment System between netupitant and palonosetron hydrochloride and placebo.

  8. Functional Living Index-Emesis questionnaire [ Time Frame: Up to day 15 ]
    Wilcoxon rank sum test or Kruskal-Wallis test will be used to test for difference of continuous variables, Functional Living Index-Emesis between netupitant and palonosetron hydrochloride and placebo.



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.


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

Inclusion Criteria:

  • Diagnosis of cancer
  • Chronic nausea over the past 4 weeks
  • Average nausea numeric rating scale >= 4/10 over the past 5 days at screening
  • Outpatient at MD Anderson Cancer Center
  • Karnofsky performance status >= 50%
  • Able to complete study assessments, including keeping a daily diary

Exclusion Criteria:

  • Delirium (i.e. Memorial Delirium Rating Scale > 13)
  • Clinical evidence of bowel obstruction at the time of study enrollment
  • Expected to use other 5HT3 antagonists or NK1 antagonists for prophylaxis during the study
  • Continuation of over-the-counter therapies for nausea and/or vomiting during the study
  • 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 National Comprehensive Cancer Network (NCCN) guideline within 2 weeks of study enrollment
  • On scheduled potent CYP3A4 inducers at the time of study enrollment (avasimibe, carbamazepine, phenytoin, rifampin, efavirenz, nevirapine, barbiturates, systemic glucocorticoids, modafinil, oxcarbazine, phenobarbital, pioglitazone, rifabutin, St. John's wort, troglitazone)
  • On scheduled CYP3A4 substrates with narrow safety range at the time of study enrollment (alfentanil, cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus, tacrolimus)
  • 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
  • Unwilling to provide informed consent
  • Severe renal impairment (calculated creatinine clearance =< 29 cc/min)

    • Calculated creatinine clearance can be done within 14 days of study enrollment
  • Severe liver impairment (Child-Pugh score > 9)

    • Total (T.) bilirubin, albumin, prothrombin time, and serum creatinine tests can be done within 14 days of study enrollment (only if not performed in the last 14 days)
  • 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 beta-human chorionic gonadotropin (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


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Helsinn Healthcare SA
Investigators
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Principal Investigator: David Hui M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03040726    
Other Study ID Numbers: 2016-0843
NCI-2017-00599 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0843 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Palonosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action