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New treatment option for Fallopian Tube Endometrioid Adenocarcinoma
Official title Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
ClinicalTrials.gov ID: NCT06580314
What this study is testing
What is Bevacizumab?
Bevacizumab is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for fallopian tube endometrioid adenocarcinoma.
Also referred to as ABP 215, ABP-215.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the...
- High grade serous
- High grade endometrioid, and/or
- Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic)
- Submission of pathology report is required
See the full eligibility criteria
- Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:
- High grade serous
- High grade endometrioid, and/or
- Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic)
- Submission of pathology report is required
- Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer
- Patients must have:
- Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)
- Submission of testing report is required. OR
- BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)
- Submission of testing report is required
- Patient must have undergone cytoreductive surgery (primary or interval)
- Patients must have completed first line platinum-based therapy prior to registration:
- Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated
- For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy
- Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle
- Patients must not have received an investigational agent during their first line course of chemotherapy
- Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)
- Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression following completion of this chemotherapy course...
- Patients must be assigned by chance at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)
- No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 9 g/dl
- Creatinine clearance (CrCL) of \> 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- No active infection requiring parental antibiotic(s)
- No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
- No current inability to swallow orally administered medication
- No history of myelodysplastic syndrome and/or acute myeloid leukemia
- No history of allogeneic bone marrow transplant
- No concomitant use of strong or moderate CYP3A inducers
- No known hypersensitivity to olaparib or any of the excipients of the product
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Fayetteville, Arkansas, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Antioch, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Bellflower, California, United States
- Berkeley, California, United States
- Beverly Hills, California, United States
- Burbank, California, United States
- Burlingame, California, United States
- Cameron Park, California, United States
- Carmichael, California, United States
- Castro Valley, California, United States
- Davis, California, United States
+ 444 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Fayetteville, Arkansas, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States and 458 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.