Last reviewed · How we verify
Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer
Phase 2 trial testing Olaparib in Ovarian Cancer in 3 participants. Terminated before completion.
| Lead sponsor | Sarah E Taylor |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 3 |
| Start date | 29 June 2020 |
| Primary completion | 31 May 2023 |
| Estimated completion | 31 May 2023 |
| Sites | 1 location across United States |
Sarah E Taylor
18 and older, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The time to next therapy from completion of platinum-based therapy for treatment of recurrence until initiation of post-olaparib treatment.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 3 |
Progression-free survival (PFS) defined as time from enrollment until detected recurrence or progression of disease, via Response Evaluation Criteria in Solid Tumors , or death from any cause.. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered pr
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 3 |
Overall survival as defined as the time from enrollment to death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 15 |
The number of patients that experience Adverse Events per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 that were determined to be possibly, probably or definitely related to study treatment.
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Olaparib | 1 |
Time frame: Adverse Events collected for up to 35 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Olaparib |
|---|---|---|
| Hypertension | Vascular disorders | — |
| Renal calculi | Renal and urinary disorders | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Hypertension | Vascular disorders | — |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | — |
| Sinus bradycardia | Cardiac disorders | — |
| Fatigue | General disorders | — |
Data from ClinicalTrials.gov NCT04377087 adverse events section.
The purpose of this study is to test if delaying the start of the olaparib until there is a rise in a tumor marker called CA-125 will result in a longer time until the next or different treatment for the patient's cancer. The study will also evaluate how delaying the start of maintenance therapy will affect symptoms; physical functioning; quality of life; and impact on finances.
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04377087.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing