Study for Patients with BRCA Mutated Ovarian, Breast, Pancreatic, Prostate, and Endometrial Cancers Continuing Olaparib Treatment

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What is this study about?

This clinical trial is focused on patients with certain types of cancer, including BRCA Mutated Ovarian Cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, gBRCA mutated metastatic pancreatic cancer, prostate cancer, and endometrium cancer. The study involves a medication called Olaparib, which is available in the form of film-coated tablets. Olaparib is a chemical substance used to treat these cancers, and it is also known by its code name, AZD2281.

The purpose of this study is to continue providing treatment to patients who have completed a previous cancer study with Olaparib and are still benefiting from it. The study aims to ensure the safety and tolerability of the ongoing treatment. Patients will continue to receive Olaparib if they are judged by their doctor to be benefiting from the treatment. The study will monitor the patients’ health and any side effects that may occur during the treatment period.

Participants in this study will take Olaparib tablets orally, with the treatment period lasting up to 123 days. The study will keep track of any serious side effects or important medical events that happen up to 30 days after the last dose of the study drug. This trial is designed to help patients who are already experiencing positive effects from Olaparib to continue their treatment safely.

1 joining the study

Participation begins after completing a previous oncology study with olaparib and being assessed by the investigator as benefiting from continued treatment.

Eligibility requires a signed and dated informed consent form and ongoing clinical benefit from a prior study with an AstraZeneca compound.

2 treatment administration

The treatment involves taking Lynparza film-coated tablets, available in 100 mg and 150 mg doses.

The tablets are taken orally. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

3 monitoring and safety

The main objective is to provide continuous treatment while monitoring safety and tolerability.

Serious adverse events (SAEs) and adverse events of special interest (AESIs) are monitored until 30 days after the last dose of the study drug.

4 study duration

The estimated end date for the study is December 30, 2030.

The study aims to ensure that patients continue to benefit from the treatment throughout its duration.

Who Can Join the Study?

  • The patient must provide a signed and dated written document called an Informed Consent Form (ICF), which shows they agree to participate in the study.
  • The patient must currently be benefiting from treatment in a previous study with a medication from AstraZeneca, as determined by the study doctor.
  • The patient must have been part of a previous cancer study with an AstraZeneca medication called olaparib and must still be benefiting from this treatment. The previous study could have been open (where both the patient and doctor know the treatment) or blinded (where the treatment is unknown to the patient or doctor until the study ends).
  • The study is open to both male and female patients.
  • The study includes patients who may be considered part of a vulnerable population, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who do not have a mutation in the BRCA gene. The BRCA gene is related to breast and ovarian cancer risk.
  • Patients who do not have epithelial ovarian cancer. This is a type of cancer that starts in the cells on the surface of the ovary.
  • Patients who do not have metastatic breast cancer. This means the cancer has spread to other parts of the body.
  • Patients who do not have platinum-sensitive relapsed ovarian cancer. This refers to ovarian cancer that responds to platinum-based chemotherapy after it has returned.
  • Patients who do not have gBRCA mutated metastatic pancreatic cancer. This is pancreatic cancer with a specific genetic mutation that has spread to other parts of the body.
  • Patients who do not have prostate cancer. This is cancer that occurs in the prostate, a small gland in men that produces seminal fluid.
  • Patients who do not have endometrium cancer. This is cancer that starts in the lining of the uterus.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of a vulnerable population as defined by the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Universitario De Navarra Pamplona Spain
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Ospedale Vito Fazzi Lecce Lecce Italy
Orszagos Onkologiai Intezet Budapest Hungary
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universita Cattolica Del Sacro Cuore Rome Italy
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Complex Oncological Center Plovdiv EOOD Plovdiv Bulgaria
Hospital Universitario Virgen De Las Nieves Granada Spain
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie Olsztyn Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Medical Center Nadezhda Clinical EOOD Sofia Bulgaria
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Degli Studi Di Verona Verona Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Fakultni Nemocnice Brno Brno Czechia
Universita’ Politecnica Delle Marche Ancona Italy
Alessandro Manzoni Hospital Lecco Italy
Hopital Prive Des Cotes D’armor Plerin France
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Medical Center Ljubljana Ljubljana Slovenia
University Hospital Olomouc Olomouc Czechia
Universita Degli Studi Di Brescia Brescia Italy
Budapesti Szent Margit Korhaz Budapest Hungary
Hospital Paul Brousse Villejuif France
University Hospital Ostrava Ostrava Czechia
Cgvqky Lfdh Brobqn Lyon France
Iusyprhp Cvokte Dqiwownrcsdkabjed L'hospitalet De Llobregat Spain
Csoqlrch Haoxnewjvyjn Uhxwczkkmqgxe Dm Vnwa Vigo Spain
Ntld Ictvahtrzhr Mjfsxeir Rfhkeflex Szvg Grzepnica Poland
Ucdlsaxvbuewftvltcd Sfnuq Lund Sweden
Fvqxopix nlomatdyv Mirrh a Hvikaxj Prague Czechia
Adjkxky Orocmpdnonr Pxl Liloyvzjckohzwxee Cjldjyisyw Catania Italy
Hgscknfs Ukuaqdqbcrklw Dnnlcmnn Donostia / San Sebastian Spain
Arqoywq Uozju Smvbhgykt Lexbkz Dn Bnzxbga Bologna Italy
Hlppgwxt Vwhh dytroqsa Barcelona Spain
Caedsl Ohlkn Ltptqwa Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
30.09.2020
Bulgaria Bulgaria
Recruiting
30.09.2020
Czechia Czechia
Recruiting
30.09.2020
France France
Recruiting
30.09.2020
Germany Germany
Recruiting
30.09.2020
Hungary Hungary
Recruiting
30.09.2020
Italy Italy
Recruiting
30.09.2020
Poland Poland
Recruiting
30.09.2020
Portugal Portugal
Recruiting
30.09.2020
Slovenia Slovenia
Recruiting
30.09.2020
Spain Spain
Recruiting
30.09.2020
Sweden Sweden
Recruiting
30.09.2020

Trial locations

Investigated drugs:

Olaparib is a medication used in this clinical trial. It is designed to help patients who have completed a previous oncology study and are still benefiting from the treatment. Olaparib works by interfering with the cancer cells’ ability to repair their DNA, which can help to slow down or stop the growth of cancer. This trial aims to continue providing Olaparib to patients who are experiencing positive effects, while also monitoring their safety and how well they tolerate the medication.

BRCA Mutated Ovarian Cancer – This type of ovarian cancer occurs in individuals with mutations in the BRCA1 or BRCA2 genes. These mutations can lead to the development of cancer in the cells of the ovaries. The disease often progresses with the growth of tumors in the ovarian tissue, which may spread to other parts of the body if not managed.

Epithelial Ovarian Cancer – This is the most common form of ovarian cancer, originating in the layer of cells covering the ovaries. It typically begins with abnormal cell growth in the ovarian epithelium. As the disease progresses, these cells can form tumors and potentially spread to nearby organs.

Metastatic Breast Cancer – Also known as stage IV breast cancer, this condition occurs when cancer cells from the breast spread to other parts of the body. The disease progresses as these cells invade distant organs such as the bones, liver, or lungs. It is characterized by the growth of secondary tumors in these areas.

Platinum Sensitive Relapsed Ovarian Cancer – This type of ovarian cancer refers to cases where the disease returns after initial treatment with platinum-based chemotherapy. The cancer is considered “platinum-sensitive” if it responds to this treatment again. The progression involves the recurrence of tumors in the ovaries or other areas.

gBRCA Mutated Metastatic Pancreatic Cancer – This form of pancreatic cancer is associated with inherited mutations in the BRCA1 or BRCA2 genes. It progresses as cancer cells spread from the pancreas to other parts of the body. The disease is marked by the development of tumors in the pancreas and potentially other organs.

Prostate Cancer – This cancer develops in the prostate gland, which is part of the male reproductive system. It often begins with slow-growing tumors that may not cause symptoms initially. As it progresses, the cancer can spread to nearby tissues or distant parts of the body.

Endometrial Cancer – This type of cancer originates in the lining of the uterus, known as the endometrium. It typically starts with abnormal cell growth in this lining. The disease progresses as these cells form tumors, which can invade the uterine wall and potentially spread to other areas.

Trial ID:
2024-512982-15-00
Protocol code:
D0817C00098
Trial Phase:
Therapeutic confirmatory (Phase III)

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