Clinical trial · Interventional
A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib
A Proof of Concept Clinical Trial of the Combination Cediranib-Olaparib at the Time of Disease Progression on Olaparib in Ovarian Cancer
NCT02340611CI-TRIAL-00033293completedPhase 2ClinicalTrials.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 a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful adding investigational drug cediranib to olaparib after disease progression on olaparib alone in patients with ovarian 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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cediranib and Olaparib
- description
- Cediranib, 20 mg , orally, once a day, every day. Olaparib, 150 mg or 200 mg (depending on previous treatment dose), orally, once a day, every day.
- interventionNames
- Drug: Olaparib
- Drug: Cediranib
Primary outcomes (1)
- measure
- Percentage of patients whose cancer shrinks or disappears after treatment
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Percentage of decrease in CA-125 levels after treatment
- timeFrame
- 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Performance status 2 or less * Ovarian cancer, high grade serous or high grade endometrioid histology subtype * Radiographically documented disease progression per RECIST 1.1 * Progression on olaparib therapy after an initial good response (more than 6 months) * Patients must have adequate bone marrow, renal and hepatic function per local laboratory reference range * Ongoing prior toxicities related to previous treatments recovered to grade 2 or less * LVEF\>50% by echocardiograms or MUGA * Urine dipstick for proteinuria \<2+ * Willing to undergo tumour biopsy pre-treatment * Life expectancy of greater than 3 months * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Current bowel obstruction * Known brain metastases * Mean QTc \>470 msec (with Bazett's correction) in screening ECG or history of familial long QT syndrome. * Uncontrolled intercurrent illness including, but not limited to hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * A New York Heart Association classification of III or IV requiring concurrent use of drugs or biologics with proarrhythmic potential. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or cediranib * Unable to swallow orally administered medication and/or gastrointestinal disorders likely to interfere with absorption of the study medication. * Myelodysplastic syndrome/acute myeloid leukaemia * Immuno-compromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with known active hepatitis (i.e.,hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids.
References
Publications (0)
Data not yet available
No reference posted for this study.