Last updated: August 24, 2021
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting
Phase
1/2
Condition
Fallopian Tube Cancer
Treatment
N/AClinical Study ID
NCT03462212
3329
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women aged >=18 years at the time of study inclusion;
- Patients with newly diagnosed, histologically confirmed, high grade serous, high gradeendometrioid, FIGO stage IIIB-C-IV epithelial ovarian cancer, primary peritonealcancer and / or Fallopian-tube cancer. Patients with mixed histology (carcinosarcoma)are eligible providing that high grade tumor represent more than 50% of the totalhistology. Stage III patients should have had one attempt at optimal debulking surgery (upfrontor interval debulking). Stage IV patients must have had either a biopsy and/or upfrontor interval debulking surgery;
- Archival tumor tissue available. At progression fresh biopsy is optional for patientswilling to submit ;
- ECOG Performance Status of 0-1;
- Measurable and not measurable disease;
- Adequate renal and hepatic function, defined as:
- Total serum bilirubin ≤ 1.5 institutional ULN unless patient has Gilbert'ssyndrome in which case total serum bilirubin must be <2 ULN for the institutionAST and/or ALT ≤ 2.5 x ULN for the institution. (or ≤ 5 x ULN if liver metastasesare present);
- Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, thenalkaline phosphatase liver fraction must be < 1.5 ULN)
- Serum creatinine ≤ 1.5 x ULN for the institution (or calculated creatinineclearance ≥ 45 mL/min/1.73 m2);
- Adequate bone marrow function, defined as:
- Total leukocytes 2.5 x 109/L;
- ANC 1.5 x 109/L;
- Platelet count 100 x 109/L;
- Able to understand and give written informed consent;
- Females of childbearing potential must have a negative serum pregnancy test within 7days prior to study enrollment.
Exclusion
Exclusion Criteria:
- Women who are pregnant or lactating;
- Presence of brain or other central nervous system metastases, not adequatelycontrolled by treatment;
- Prior Anticancer treatment;
- Inadequate recovery from any prior surgical procedure or having undergone any majorsurgical procedure within 3 weeks prior to randomization;
- Another primary malignancy except for:
- Curatively treated non-melanoma skin cancer;
- Breast cancer treated curatively ≥5 years ago, or other solid tumor treatedcuratively ≥5 years ago, without evidence of recurrence;
- Synchronous endometrioid endometrial cancer (except for Stage 1A G1/G2);
- Known active HIV, hepatitis B or C infection;
- Concurrent treatment with immunosuppressive or investigational agents;
- History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascularaccident (CVA) / stroke or transient ischemic attack (TIA) or subarachnoid haemorrhagewithin _6 months prior to the first study treatment);
- Clinically significant (i.e. active) cardiovascular disease, including:
- Myocardial infarction or unstable angina within _6 months prior to the firststudy treatment;
- New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF);
- Serious cardiac arrhythmia requiring medication (with the exception of atrialfibrillation or paroxysmal supraventricular tachycardia);
- Peripheral vascular disease > grade 3 (i.e.symptomatic and interfering withactivities of daily living requiring repair or revision);
- Serious active infection requiring i.v. antibiotics at enrolment;
- Known hypersensitivity to any of the study drugs or excipients (including cremophorand hamster Ovary cell products);
- Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer,etc.), physical examination or laboratory findings that may interfere with the plannedtreatment, affect patient compliance or place the patient at high risk from treatmentrelated complications;
- Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder ordefect that would interfere with absorption of study drug;
- Received administration of strong CYP1A2 or CYP3A4 inhibitors ≤7 days prior to firstdose of Rucaparib or have on-going requirements for these medications.
Study Design
Total Participants: 290
Study Start date:
March 17, 2021
Estimated Completion Date:
March 01, 2025
Study Description
Connect with a study center
Ospedale Mater Salutis
Legnago,
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan,
ItalyActive - Recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples,
ItalyActive - Recruiting
Azienda Ospedaliera di Perugia
Perugia,
ItalyActive - Recruiting
Nuovo Ospedale degli Infermi
Ponderano,
ItalyActive - Recruiting
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, 00168
ItalyActive - Recruiting
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS
Turin,
ItalyActive - Recruiting
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