CDSCO panel approves AstraZeneca's Protocol Amendment proposal for Anticancer Drug AZD5305 study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major AstraZeneca's proposal for the protocol amendment of the clinical trial titled "A randomised 2 cohort double blind placebo controlled phase III study of AZD5305 in combination with physicians choice new hormonal agents in patients with HRRm and non-HRRm metastatic castration sensitive prostate cancer (EvoPAR-Prostate01)"
This came after the firm presented protocol amendment version 4.0 dated 23 May 2024 protocol no.n D9723C00001. The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician’s choice NHA relative to placebo + physician’s choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC).
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.