A study to evaluate the safety and effect of AkynzeoÃ?Â® to treat nausea and vomiting caused after chemotherapy.

An open label, single arm, multicentric, observational study to evaluate safety and effectiveness of AkynzeoÃ?Â®, an oral fixed dose combination of netupitant and palonosetron in the management of CINV, in the real world settings of India

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/02/023586

Enrollment

360

Registered

2020-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Intervention1: AkynzeoÃ?Â® (Netupitant 300mg and Palonosetron 0.50mg): Dose- 1 capsule of Akynzeo (300 mg Netupitant and 0.556 mg Palonosetron) before chemotherapy Frequency- One capsule to be adminis

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient scheduled to receive a highly or moderately emetogenic chemotherapy (HEC/MEC). 2.Scheduled to receive Akynzeo as per current practice, at the judgment of Investigator. 3. Male/females patients age above Ã¢â?°Â¥18 years 4. Willing to be part of study and for follow up. 5. Willing to provide written inform consent form.

Exclusion criteria

Exclusion criteria: 1. Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5. 2. Bone marrow or stem-cell transplant patients. 3. Serious cardiovascular disease history or predisposition to cardiac conduction abnormalities. 4. Vomiting, retching, or more than mild nausea within 24 h before day 1. 5. Women of child bearing potential who are pregnant, planning on becoming pregnant or breast feeding. 6. Hypersensitivity to active substances, excipients or other ingredients of Akynzeo (NEPA). 7. Patient currently enrolled in another clinical trial where antiemetic treatment is pre-specified by the study protocol.

Design outcomes

Primary

Measure	Time frame
1. Overall complete response rate (0 to 120 hrs.) 2. Occurrence /Frequency or incident rate of treatment emergent adverse eventsTimepoint: 1. upto 120hrs 2. Overall study duration	—

Secondary

Measure	Time frame
1. Complete response rate during acute phase (0 to 24 hrs.) 2. Complete response rate during delayed phase (24 to 120 hrs.) 3. Complete control rate during overall phase (0 to 120 hrs.) 4. Severity of nausea assessed using a Visual Analogue Scale (VAS)Timepoint: 1. upto 24hrs 2. 24hrs to 120hrs 3. 0hrs to 120hrs	—

Countries

India

Contacts

Public ContactDr Sagar Bhagat

Glenmark Pharmaceuticals Ltd.

Sagar.Bhagat@glenmarkpharma.com97571828808

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026