Clinical trial · Interventional
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
NCT00750425CI-TRIAL-00004554completedPhase 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)
Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cediranib (RECENTIN TM, AZD2171) | Drug | Cediranib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone
- interventionNames
- Drug: cediranib (RECENTIN TM, AZD2171)
Primary outcomes (1)
- measure
- To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
- timeFrame
- PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Secondary outcomes (1)
- measure
- Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.
- timeFrame
- Until study drug is discountinued
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists. * Estimated life expectancy of at least 8 weeks * WHO performance status (PS) 0-2. Exclusion Criteria: * Unstable brain/meningeal metastases * Biochemistry/haematology results outside of required ranges * History of significant GI impairment * Inadequate bone marrow reserve
References
Publications (0)
Data not yet available
No reference posted for this study.