The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
Source : Importé depuis le centre
Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.
Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH). One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and unknown genetic and other mechanisms.
Once determined, this signature will be prospectively applied to ARIEL2 PART 2 and ARIEL3. This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3.
This study will include 2 parts:
PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received ≥1 prior platinum-based regimen and had platinum-sensitive disease
PART 2 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens
Source : Importé depuis le centre
RECRUTEMENT
Profil des participants
Limites d'âge
minimum : 18 ans
Condition médicale (spécialité visée)
Domaine de recherche
Donnée non disponible
Critères de sélection
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Ovarian cancer
Donnée non disponible
rucaparib
Inconnu
Ovarian cancer
État du recrutement
unknown
rucaparib
Données à jour depuis :
6 juin 2023
SITES ET CONTACTS
Centre principal
providence alaska medical center
ANCHORAGE, ALASKA, UNITED STATES
Recrutement local
—
FERMÉ
Centres au Québec
Centre hospitalier de l'Université de Montréal
MONTRÉAL, QUÉBEC, CANADA
Recrutement local
—
FERMÉ
Centre hospitalier Universitaire de Québec
QUÉBEC, QUÉBEC, CANADA
Recrutement local
—
FERMÉ
Université de Montréal
MONTRÉAL, QUÉBEC, CANADA
Recrutement local
—
FERMÉ
Centre intégré universitaire de santé et de services sociaux du Centre-Ouest-de-l’Île-de-Montréal
MONTRÉAL, QUÉBEC, CANADA
Recrutement local
—
FERMÉ
jewish general hospital
MONTREAL, QUEBEC, CANADA
Recrutement local
—
FERMÉ
chu de québec - université laval
QUÉBEC, QUEBEC, CANADA
Recrutement local
—
FERMÉ
Aussi disponible à: LONDON, LONDON, (LONDON CITY), LONDON, (LONDON, CITY OF), MANCHESTER, (ENGLAND), NEWCASTLE UPON TYNE, COLUMBUS, (OHIO), OKLAHOMA CITY, (OKLAHOMA), PARIS, VILLEJUIF, (ILE-DE-FRANCE), TOULOUSE, (CEDEX 9), NANTES, ...
et 67 autres villes.
Dernière modification :
6 juin 2023
Données à jour depuis :
21 mars
Origine des données :
clinicaltrials.gov
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles
Identifiant
CO-338-017
Titre
A study of rucaparib in patients with platinum-sensitive, relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (ariel2)
The following eligibility criteria pertain to patients enrolling into PART 2 of the study:
Inclusion:
* Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
* Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen
* Relapsed/progressive disease as confirmed by CT scan
* Have biopsiable and measurable disease. Note: biopsy is optional for patients known to harbor a deleterious gBRCA mutation
* Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Exclusion:
* History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed \>6 months prior and/or bone marrow transplant \>2 years prior to first dose of rucaparib).
* Prior treatment with any PARP inhibitor
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
* Hospitalization for bowel obstruction within 3 months prior to enrollment
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Ovarian cancer
Donnée non disponible
rucaparib
Inconnu
Ovarian cancer
État du recrutement
unknown
rucaparib
Données à jour depuis :
6 juin 2023
Description de l'étude
Description de l'étude
Résumé de l'étude
The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
Source : Importé depuis le centre
Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.
Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH). One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and unknown genetic and other mechanisms.
Once determined, this signature will be prospectively applied to ARIEL2 PART 2 and ARIEL3. This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3.
This study will include 2 parts:
PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received ≥1 prior platinum-based regimen and had platinum-sensitive disease
PART 2 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
79
centres
CENTRE HOSPITALIER UNIVERSITAIRE DE QUÉBEC
Québec
QUÉBEC, CANADA
Recrutement local
État du recrutement:
FERMÉ
CENTRE HOSPITALIER DE L'UNIVERSITÉ DE MONTRÉAL
Montréal
QUÉBEC, CANADA
Recrutement local
État du recrutement:
FERMÉ
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU CENTRE-OUEST-DE-L’ÎLE-DE-MONTRÉAL
Montréal
QUÉBEC, CANADA
Recrutement local
État du recrutement:
FERMÉ
UNIVERSITÉ DE MONTRÉAL
Montréal
QUÉBEC, CANADA
Recrutement local
État du recrutement:
FERMÉ
ADDENBROOKE'S HOSPITAL
Cambridge
CAMBRIDGESHIRE, UNITED KINGDOM
Recrutement local
État du recrutement:
FERMÉ
ALTUS RESEARCH
Lake worth
FLORIDA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
BC CANCER AGENCY - FRASER VALLEY CENTRE
Surrey
BRITISH COLUMBIA, CANADA
Recrutement local
État du recrutement:
FERMÉ
BEATSON WEST OF SCOTLAND CANCER CENTRE
Glasgow
LANARKSHIRE, UNITED KINGDOM
Recrutement local
État du recrutement:
FERMÉ
BRITISH COLUMBIA CANCER AGENCY
Kelowna
BRITISH COLUMBIA, CANADA
Recrutement local
État du recrutement:
FERMÉ
CALIFORNIA PACIFIC MEDICAL CENTER
San francisco
CALIFORNIA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
6 juin 2023
Données à jour depuis :
21 mars
Origine des données :
clinicaltrials.gov