N/A
Completed N=36
Preoperative Olaparib Endometrial Carcinoma Study (POLEN)
Source: ClinicalTrials.gov NCT02506816 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Nov 2019
Primary outcomePrimary: Expression of Cell Cycle-related Proteins — 46.1; 0.8; 0.7 score on a scale — p=0.033
Summary
The primary objective of this study is to identify, in human tumour samples, biomarker changes associated to short exposure to AZD2281 as potential predictors of activity in Endometrial Carcinoma (EC).
This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety are not a primary objective of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expression of Cell Cycle-related Proteins |
46.1; 0.8; 0.7 | 0.033 sig |
| SECONDARY Protein Expression of Biomarkers Related to PARP-inhibition |
10.3; -46.21; -9.4; 76.9; 3.2; -0.2 | 0.03 sig |
| SECONDARY Plasma Levels of Olaparib |
6.55; 5.61; 6.49; 4.7 | — |
| SECONDARY Number of Participants With Olaparib-Associated Toxicities |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have histologically-confirmed type I primary endometrial carcinoma (EC). Diagnosis biopsy must contain 3-12 mg of tumour cellularity/stroma (Tumour: 5-20 mm) and this will be checked in the central laboratory for this trial. If tumour cellularity/stroma is inadequate, one re-biopsy with adequate tumour cellularity/stroma will be mandatory before study entry.
- WHO performance status ≤ 2.
- Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb >10g/dL.
- Adequate liver function as shown by:
serum bilirubin ≤ 1.5 x ULN INR 1.5 x ULN Active (acute or chronic) or uncontrolled severe infections Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis A known history of HIV seropositivity.
- Patients with an active, bleeding diathesis.
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of AZD2281).
- History of noncompliance to medical regimens.
- Patients unwilling to or unable to comply with the protocol.
Data sourced from ClinicalTrials.gov (NCT02506816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.