Clinical trial · Interventional
A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours
An Open-label, Fixed-sequence Study to Assess the Effect of Repeated Doses of Capivasertib on the Pharmacokinetics of Oral Midazolam (a CYP450 3A Probe) in Patients With Advanced Solid Tumours
NCT04958226CI-TRIAL-00073294completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumour | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capivasertib | Drug | Capivasertib | ALIAS |
| Midazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Midazolam + Capivasertib)
- description
- Midazolam will be administered on Cycle 1 Day 1 and Cycle 1 Day 8. Capivasertib will be administrated from Cycle 1 Day 2 as an intermittent schedule (4 days on/3 days off) until discontinuation. On Cycle 1 Day 12, Midazolam will be administrated with Capivasertib.
- interventionNames
- Drug: Capivasertib
- Drug: Midazolam
Primary outcomes (2)
- measure
- 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)
- description
- Area under the plasma concentration-time curve from zero to infinity
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants with documented evidence of locally advanced inoperable or metastatic solid tumours who may be suitable to receive capivasertib treatment. 2. Eastern Cooperative Oncology Group/World Health Organization performance status 0 to 1 and with minimum life expectancy for 12 weeks. 3. Participant should have at least one lesion that can be assessed by computed tomography/magnetic resonance imaging or plain X-ray at baseline. 4. Body mass index within the range 18 to 32 kg/m\^2 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. 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. 2. Participants with diabetes mellitus type I or participants with diabetes mellitus type II requiring insulin treatment. 3. Undergone a major surgery within 4 weeks of the first dose of capivasertib. 4. 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. 5. Participants with spinal cord compression or brain metastases. 6. Participants with severe or uncontrolled systemic diseases, active bleeding diatheses, or active infection. 7. Previous allogeneic bone marrow transplant or solid organ transplant. 8. Known immunodeficiency syndrome.
References
Publications (1)
- DERIVEDMiller C, Sommavilla R, O'Bryant CL, Barve M, Dowlati A, Luke JJ, Khatun M, Morris T, Cullberg M. Pharmacokinetic study of capivasertib and the CYP3A4 substrate midazolam in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2024 Aug;94(2):223-235. doi: 10.1007/s00280-024-04667-3. Epub 2024 Apr 20. PMID 38643311