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Clinical Trial Summary

This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose. In addition, expansion cohort(s) at potential therapeutic dose(s) in patients with or without ESR1 mutations will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of AZD9496


Clinical Trial Description

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD9496 in Women with Estrogen Receptor Positive HER-2 Negative Advanced Breast Cancer ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02248090
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date October 22, 2014
Completion date April 3, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04541433 - A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer Phase 1
Active, not recruiting NCT03616587 - Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. Phase 1
Terminated NCT03596658 - SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer Phase 1
Recruiting NCT06188520 - A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors Phase 1/Phase 2