A Phase 2 interventional study of KU-0059436 (AZD2281)(PARP inhibitor) and KU-0059436 (AZD2281)(PARP inhibitor) in Ovarian Neoplasm, sponsored by AstraZeneca. Completed at 11 sites in 5 countries. Open to female participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 58 is close to the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Also known as: Olaparib
oral
Confirmed Objective Tumour Response (According to Response Evaluation Criteria In Solid Tumors (RECIST)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: Baseline, every 8 also at study termination or initiation of confounding anti-cancer therapy.
Clinical Benefit (CB)
Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)
Time frame: End of study
Duration of Response
Duration of response to olaparib
Time frame: End of study
Best Percentage Change in Tumour Size
The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
Time frame: End of study
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.
Time frame: End of study
The first patient was enrolled on June 11, 2007 and efficacy and safety data were collected up to the data cut-off of March 17, 2009. Patients were enrolled at 12 centres in 5 countries: Australia, Germany, Spain, Sweden and the USA.
| Milestone | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| Started | 24 | 33 |
| Completed | 7 | 17 |
| Not completed | 17 | 16 |
| Withdrew: Death | 1 | 1 |
| Withdrew: Lack of efficacy | 16 | 10 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Non-compliance | 0 | 1 |
| Withdrew: Intercurrent illness | 0 | 1 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease from baseline in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Participants | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| PP Analysis Set | 3 | 11 |
| ITT Analysis Set | 3 | 11 |
Clinical Benefit (CB) is defined as the percentage of patients with a RECIST tumour response of confirmed complete response, partial response or stable disease for ≥8 weeks)
| Percentage of participants | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| Clinical Benefit (CB) | 45.5 (26.9 to 65.3) | 71.0 (53.4 to 83.9) |
Duration of response to olaparib
| Days | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| Duration of Response | 242 (169 to 288) | 301 (126 to 506) |
The best % change (reduction) from baseline in tumour size (defined as the sum of the longest diameters as measured among all target lesions).
| Percent change | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| Best Percentage Change in Tumour Size | -5.1 (-85.7 to 66.1) | -25.8 (-100.0 to 150.0) |
Progression-Free Survival (PFS) is defined as the time from first dose to the earlier date of radiologic progression (as per RECIST criteria) or death by any cause in the absence of objective progression.
| Days | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| Progression-Free Survival (PFS) | 62.5 (56 to 113) | 226 (105 to 338) |
Collected over From baseline, every visit until 30 days after last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olaparib 100 mg bd | 10/24 (41.7%) | 7/24 (29.2%) | 23/24 (95.8%) |
| Olaparib 400 mg bd | 11/33 (33.3%) | 12/33 (36.4%) | 33/33 (100%) |
| Event | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| Intestinal ObstructionGastrointestinal disorders | 0/24 | 2/33 |
| NauseaGastrointestinal disorders | 1/24 | 2/33 |
| VomitingGastrointestinal disorders | 1/24 | 2/33 |
| NeutropeniaBlood and lymphatic system disorders | 1/24 | 1/33 |
| Cardiac Failure CongestiveCardiac disorders | 1/24 | 0/33 |
| Abdominal PainGastrointestinal disorders | 1/24 | 0/33 |
| Large Intestinal ObstructionGastrointestinal disorders | 1/24 | 1/33 |
| Blood Pressure IncreasedInjury, poisoning and procedural complications | 1/24 | 0/33 |
| HyponatraemiaMetabolism and nutrition disorders | 1/24 | 0/33 |
| EncephalopathyNervous system disorders | 1/24 | 0/33 |
| Event | Olaparib 100 mg bd | Olaparib 400 mg bd |
|---|---|---|
| NauseaGastrointestinal disorders | 15/24 | 21/33 |
| FatigueGeneral disorders | 13/24 | 17/33 |
| DiarrhoeaGastrointestinal disorders | 7/24 | 12/33 |
| VomitingGastrointestinal disorders | 6/24 | 11/33 |
| Abdominal PainGastrointestinal disorders | 4/24 | 9/33 |
| ConstipationGastrointestinal disorders | 6/24 | 4/33 |
| AnaemiaBlood and lymphatic system disorders | 3/24 | 7/33 |
| HeadacheNervous system disorders | 4/24 | 7/33 |
| Urinary Tract InfectionInfections and infestations | 5/24 | 2/33 |
| RashSkin and subcutaneous tissue disorders | 5/24 | 5/33 |
| Age, Continuous(Years) | Olaparib 100 mg bd | Olaparib 400 mg bd | Total |
|---|---|---|---|
| Mean | 55.6 ± 8.02 | 56.8 ± 10.49 | 56 ± 9 |
| Sex: Female, Male(Participants) | Olaparib 100 mg bd | Olaparib 400 mg bd | Total |
|---|---|---|---|
| Female | 24 | 33 | 57 |
| Male | 0 | 0 | 0 |
| BRCA mutation(Participants) | Olaparib 100 mg bd | Olaparib 400 mg bd | Total |
|---|---|---|---|
| BRCA1 | 19 | 21 | 40 |
| BRCA2 | 5 | 12 | 17 |
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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