Clinical study assessing safety and effectiveness of medicine containing two antiemetic drugs (Fosnetupitant 235 mg and Palonosetron 0.25 mg) when they are administered intravenously to prevent nausea and vomiting in cancer patients receiving chemotherapy cycles.

An open label, single arm, multicenter, prospective study to evaluate safety and effectiveness of Akynzeo® I.V. [Fosnetupitant 235 mg and Palonosetron 0.25 mg (concentrate for solution for infusion)], in the prevention of chemotherapy induced nausea and vomiting (CINV) in Indian patients (STOP-CINV study) - STOP-CINV

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/04/051951

Enrollment

178

Registered

2023-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R112- Nausea with vomiting, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient is scheduled to receive their first chemotherapy cycle of a highly emetogenic or a moderately emetogenic chemotherapy (HEC/MEC). 2. Male/female patients aged above more than or equal to 18 years to less than or equal to 75 years 3. Willing to be part of study and for follow up. 4. Willing to provide written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with serious cardiovascular disease history or predisposition to cardiac conduction abnormalities or use of medication which can cause conduction abnormalities as per treating physicians’ assessment. 2. Vomiting, retching, or more than no significant nausea within 24 h before the informed consent. 3. Women of child bearing potential who are pregnant, planning to becoming pregnant or breast feeding. 4. Known contraindication to the intravenous administration of 50 mL 5% glucose solution prior to index date 5. Hypersensitivity to active substances or excipients of Akynzeo® I.V. 6. Patient currently enrolled in another clinical trial. 7. Patients requiring multi-day chemotherapy 8. Patients who are prescribed other NK1RA and 5 HT3 RA

Design outcomes

Primary

Measure	Time frame
-Number of patients with drug related treatment emergent adverse events (TEAEs) as assessed by the treating physician -Number of patients with TEAEs -Number of patients with Serious TEAEs (STEAEs) Timepoint: [Time Frame: up to 240 hr (10 days]	—

Secondary

Measure	Time frame
1. Complete response rate (CR: no emesis, no rescue medication) during acute phase 2. Complete response rate during delayed phase 3. Complete response rate during the overall phase 4. Complete control (CC: no emesis, no rescue medication, and no nausea) during overall phase 5. Complete protection (CP: no emesis, no rescue medication and no significant nausea) during overall phase 6. Complete response rate during extended overall phase. 7. Severity of nausea assessed using a Visual Analogue Scale (VAS)Timepoint: 1.[Time Frame: 0 to 24 hrs.(10 days)] 2.[Time Frame: 24 to 120 hrs.] 3.[Time Frame: 0 to 120 hrs.] 4.[Time Frame: 0 to 120 hrs.] 5.[Time Frame: 0 to 120 hrs.] 6.[Time Frame: 0 to 240 hrs(10 days)] 7.[Time Frame: upto 240 hr (10 days)]	—

Measure

Time frame

1. Complete response rate (CR: no emesis, no rescue medication) during acute phase 2. Complete response rate during delayed phase 3. Complete response rate during the overall phase 4. Complete control (CC: no emesis, no rescue medication, and no nausea) during overall phase 5. Complete protection (CP: no emesis, no rescue medication and no significant nausea) during overall phase 6. Complete response rate during extended overall phase. 7. Severity of nausea assessed using a Visual Analogue Scale (VAS)Timepoint: 1.[Time Frame: 0 to 24 hrs.(10 days)] 2.[Time Frame: 24 to 120 hrs.] 3.[Time Frame: 0 to 120 hrs.] 4.[Time Frame: 0 to 120 hrs.] 5.[Time Frame: 0 to 120 hrs.] 6.[Time Frame: 0 to 240 hrs(10 days)] 7.[Time Frame: upto 240 hr (10 days)]

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Countries

India

Contacts

Public ContactDr Ashwini Kumar

Glenmark Pharmaceuticals Limited

sumit.bhushan@glenmarkpharma.com8800352225

Outcome results