A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours (NCT04958226) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours
United States21 participantsStarted 2021-10-15
Plain-language summary
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.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Participants with documented evidence of locally advanced inoperable or metastatic solid tumours who may be suitable to receive capivasertib treatment.
✓. Eastern Cooperative Oncology Group/World Health Organization performance status 0 to 1 and with minimum life expectancy for 12 weeks.
✓. Participant should have at least one lesion that can be assessed by computed tomography/magnetic resonance imaging or plain X-ray at baseline.
✓. Body mass index within the range 18 to 32 kg/m\^2
Exclusion criteria
✕. Radiotherapy with a wide field of radiation within 4 weeks of the first dose of capivasertib and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study intervention initiation.
✕. Participants with diabetes mellitus type I or participants with diabetes mellitus type II requiring insulin treatment.
✕. Undergone a major surgery within 4 weeks of the first dose of capivasertib.
✕. Any unresolved toxicities from prior therapies higher than CTCAE grade 2 or any unresolved toxicity that may interfere with PK assessment at the time of study intervention initiation.
✕. Participants with spinal cord compression or brain metastases.
✕. Participants with severe or uncontrolled systemic diseases, active bleeding diatheses, or active infection.
✕
What they're measuring
1
Midazolam AUCinf
Timeframe: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 1 Day 9, Cycle 1 Day 12 and Cycle 1 Day 13 (Cycle 1 is 29 days)
2
Midazolam Cmax
Timeframe: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 1 Day 9, Cycle 1 Day 12 and Cycle 1 Day 13 (Cycle 1 is 29 days)