NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer

Chemotherapy-induced Nausea and Vomiting Clinical Trial

— GIM15-NEPA  

Official title:

One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862144
• Other study ID #: GIM15-NEPA
• Status: Completed
• Phase: Phase 2
• Start date: May 12, 2016
• Est. completion date: April 3, 2017

Study information

• Verified date: March 2019
• Source: Consorzio Oncotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).

Description:

Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:

• NEPA will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle.

• Dexamethasone 12 mg will be added on day 1 only of each cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 3, 2017
• Est. primary completion date: April 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women = 18 years old

2. Histologically or cytologically confirmed diagnosis of breast cancer

3. Naïve patients

4. Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)

5. ECOG (Eastern Cooperative Oncology Group) performance status 0-2

6. Body Mass index (BMI) = 18.5

7. Written informed consent

8. If women of childbearing potential age: reliable contraceptive measures must be used during the study treatment period and up to 30 days after last NEPA administration

9. Acceptable hepatic function (<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine < 1.5 times the upper limit of normal);

10. Ability and willingness of the patient to complete the diary.

Exclusion Criteria:

1. Advanced/metastatic breast cancer

2. Patients already submitted to non-AC-based chemotherapy

3. Treatment with investigational medications in 30 days before NEPA

4. Myocardial infarction within the last 6 months

5. Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients

6. Uncontrolled diabetes mellitus

7. Nausea and vomiting at baseline

8. Chronic use of other antiemetic agent(s)

9. Patient's inability to take oral medication

10. Gastrointestinal obstruction or active peptic ulcer

11. Pregnancy or breastfeeding

12. Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for = 5 years

13. Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• Netupitant/Palonosetron

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Consorzio Oncotech

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response	The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase of all AC-based chemotherapy cycles	During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)
Secondary	Acute and Delayed Phase Complete Response	Rate of complete control (defined as no emetic episode and no need for rescue medication)	During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase
Secondary	Complete Control	Rate of complete control (defined as complete response with a maximum grade of mild nausea)	During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles (each cycle is 21 days), up to 4 cycles
Secondary	Emesis-Free	Percentage of emesis-free patients (no emetic episodes) after any AC-based chemotherapy administration.	During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days)and separately on single days of all CT cycles,up to 4 cycles.Also during the period between two consecutive cycles
Secondary	Nausea	Presence of nausea graded according to Likert scale (none, mild, moderate and severe)	During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (of 21 days)and separately on single days of all chemotherapy cycles, up to 4 cycles.Also during the period between two consecutive cycles
Secondary	Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)	Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS). Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction)	During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles
Secondary	Safety profile (according to CTCAE)	Safety profile according to CTCAE	During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles