Preoperative Olaparib Endometrial Carcinoma Study (POLEN)

NCT02506816 | Completed Results

• 2 other identifiers: MedOPP0442015-001156-30
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Endometrial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Expression of Cell Cycle-related Proteins

  We assessed the change from baseline in the histological score (H-score) of the cell cycle-related proteins on endometrial tumor tissues after 28 (+/- 5) days of olaparib-based therapy. In detail, expression of the cyclin D1, Ki67, and caspase-3 active proteins evaluated by an H-score according to the following formula: H-score= 1x(%light staining) + 2x(%moderate staining) + 3x(%strong staining). The final score ranges from 0 to 300, where 0 indicates absence of staining (corresponding to the lowest tumor proliferation rate and better outcome) and 300 the maximum staining (corresponding to the highest tumor proliferation score and worse outcome).

  Baseline and Day 28 (+/- 5)

Secondary Outcomes (3)

• Protein Expression of Biomarkers Related to PARP-inhibition

  Baseline and Day 28 (+/- 5)

• Plasma Levels of Olaparib

  Days 7,14,21 and 28

• Number of Participants With Olaparib-Associated Toxicities

  Up to 28 days (+/- 5)

Study Arms (1)

Olaparib

Drug exposure has a limited duration 28 (+/- 5) days.

Drug: Olaparib

Interventions

Olaparib DRUG

Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day).

Also known as: Lynparza

Olaparib

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patinets diagnosed with endometrial carcinoma prior surgery

You may qualify if:

• 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 \< 1.3 (or \< 3 on anticoagulants) ALT and AST ≤ 2.5x ULN
• Adequate renal function: serum creatinine ≤ 1.5 x mg/dL.
• Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN.
• Signed informed consent, including consent to tissue collection and blood samples as specified by the protocol.

You may not qualify if:

• Subjects who have received prior anticancer therapies for the current endometrial cancer (including chemotherapy, radiotherapy, antibody based therapy, hormonotherapy or surgery).
• Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
• Prior treatment with any investigational drug within the preceding 4 weeks.
• Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. However, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior the study entry. Topical or inhaled corticosteroids are allowed.
• Patients who have received immunization with attenuated live vaccines within one week of study entry (note: during study period these kind of vaccines are also not allowed).
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
• Symptomatic congestive heart failure of New York heart Association Class III or IV Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, Serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease Severely impaired lung function Uncontrolled diabetes as defined by fasting serum glucose \>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.

Sponsors & Collaborators

• MedSIR: lead
• AstraZeneca: collaborator
• Experior: collaborator

Study Sites (10)

MedSIR investigative site

A Coruña, 15006, Spain

Location

MedSIR investigative site

Barcelona, 08035, Spain

Location

MedSIR investigative site

Barcelona, 08036, Spain

Location

MedSIR investigative site

Córdoba, 14004, Spain

Location

MedSIR investigative site

Granollers, 08400, Spain

Location

MedSIR

Madrid, 28034, Spain

Location

MedSIR investigative site

Madrid, 28040, Spain

Location

MedSIR investigative site

Santiago de Compostela, 15706, Spain

Location

MedSIR investigative site

Valencia, 46009, Spain

Location

MedSIR investigative site

Vigo, 36312, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumor cells Plasma

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Results Point of Contact

• Title: Director of Operations
• Organization: Medica Scientia Innovation Research (MedSIR)

alicia.garcia@medsir.org

0034 932 214 135

Study Officials

• Antonio Llombart, MD, PhD

  Medica SIR

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 23, 2015
• Study Start: February 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: March 1, 2019
• Last Updated: November 30, 2020
• Results First Posted: November 15, 2019

Record last verified: 2019-11

Locations

ES (10)