Clinical trial · Interventional
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
NCT02822157CI-TRIAL-00049703CLIOunknownPhase 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 randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.
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 Epithelial Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly | Drug | — | UNRESOLVED |
| Olaparib | Drug | Olaparib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Olaparib
- description
- olaparib 300mg oral tablets twice daily for 28 days in 28-day cycles
- interventionNames
- Drug: Olaparib
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy
- description
- physician's choice chemotherapy
- interventionNames
- Drug: carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly
Primary outcomes (1)
- measure
- Overall Objective Response
- timeFrame
- 1 year after end inclusion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum * At least 1 previous line of chemotherapy * Measurable disease * Patients have a normal organ and bone marrow function measured within 28 days of randomization * WHO 0-2 Exclusion Criteria: * Primary platinum-refractory disease * Known hypersensitivity to olaparib * Resting ECG with QTc \> 470 msec * Concomitant use of known potent CYP3A4 inhibitors * Symptomatic uncontrolled brain metastases * Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
References
Publications (1)
- DERIVEDTattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4. PMID 35170751