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

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 360 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•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.

•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.

发起方

Glenmark Pharmaceuticals Ltd