This is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the
pharmacokinetics (PK) of midazolam, a sensitive CYP3A substrate. The PK of midazolam will
be assessed when administered alone and in combination with repeated doses of
capivasertib.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04958226.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)Status: Active
Name Not Available
This is 2 part study: Part A and Part B. Part A of the study consists of a screening
period and 3 treatment periods (midazolam alone, capivasertib alone, and midazolam +
capivasertib). During Part A, the PK profile of midazolam will be determined with and
without capivasertib.All participants will receive capivasertib treatment (4 days on/3
days off); however, at the Investigator's discretion, ER positive breast cancer patients
may also receive fulvestrant in addition to capivasertib and midazolam. Participants
completing Part A without disease progression or unacceptable toxicity, who are
considered likely to continue to benefit from further capivasertib treatment (with or
without certain standard of care treatment) in the opinion of the Investigator will enter
Part B. Part B of the study consists of an extended treatment period with capivasertib,
with or without certain standard of care treatment, followed by a 30-day safety
follow-up.
Part A of the study may be extended to allow the administration of midazolam on a
rescheduled Cycle 1 Day 8(C1D8) and Cycle 1 Day 12(C1D12 ) visit.
Lead OrganizationAstraZeneca Pharmaceuticals LP
