Phase
Condition
Ovarian Cysts
Treatment
Gemcitabine
Paclitaxel
Pegylated liposomal doxorubicin (PLD)
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants must have histologically or cytologically confirmed high grade serousor endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopiantube cancer.
Participants may be enrolled regardless of FRα expression level.
Participants must have received 1 to 4 prior lines of therapy.
Participants must have received prior treatment with the following therapies:
Platinum chemotherapy
Prior bevacizumab treatment is required, if labeled and available as standardof care per institutional guidelines, unless the participant has a documentedcontraindication or due to precautions/intolerance
Participants with known or suspected deleterious germline or somatic breastcancer gene (BRCA) mutations and who achieved a complete or partial response toplatinum-based chemotherapy must have been treated with a poly ADP-ribosepolymerase (PARP) inhibitor as maintenance treatment unless the participant isnot eligible for treatment with PARP inhibitor
Mirvetuximab soravtansine, if:
Mirvetuximab soravtansine is available in the enrollment region, and
The participant is eligible based on positive FRα expression per Food andDrug Administration (FDA)-approved (or local equivalent) test, and
The participant does not have a documented medical exception, includingchronic corneal disorders, history of corneal transplantation, or activeocular conditions requiring ongoing treatment/monitoring, such asuncontrolled glaucoma, wet age-related macular degeneration requiringintravitreal injections, active diabetic retinopathy with macular edema,macular degeneration, presence of papilledema, and /or monocular vision.
Participants must have platinum-resistant disease:
Participants who have only had 1 line of platinum-based therapy must havereceived at least 4 cycles of platinum therapy, and must have either had aresponse (CR or PR) or had non-measurable disease at the start ofplatinum-based therapy, and then progressed between > 91 days and ≤ 183 daysafter the date of the last dose of platinum.
Participants who have received 2 to 4 lines of platinum-based therapy must haveprogressed on or within 183 days after the date of the last dose of platinum.
Exclusion
Key Exclusion Criteria:
Prior therapy with an antibody-drug conjugate containing a topoisomerase 1inhibitor.
Have primary platinum-refractory disease, defined as ovarian cancer that did notrespond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-lineplatinum-containing regimen.
History of another malignancy within 3 years before the first dose of study drug, orany evidence of residual disease from a previously diagnosed malignancy. Exceptionsare malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of thecervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterinecancer.
Known active central nervous system metastases or carcinomatous meningitis.Participants with previously treated brain metastases may participate provided theyare clinically stable for at least 4 weeks prior to study entry after brainmetastasis treatment, they have no new or enlarging brain metastases, and are offcorticosteroids and anticonvulsants prescribed for symptoms associated with brainmetastases for at least 7 days prior to the first dose of study drug. Participantswith suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
Hospitalization or clinical symptoms due to gastrointestinal obstruction within thepast 91 days or radiographic evidence of gastrointestinal obstruction at the time ofscreening. Enrollment of participants who currently require parenteral nutritionmust be discussed with the study medical monitor to determine eligibility.
Ascites requiring frequent paracentesis (more often than approximately every 4weeks) for symptomatic management. Enrollment of participants with an indwellingperitoneal catheter must be discussed with the medical monitor to determineeligibility.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
University of California San Diego Moores Cancer Center
La Jolla, California 92093
United StatesActive - Recruiting
USCF Mission Bay
San Francisco, California 94158
United StatesActive - Recruiting
Norwalk Hospital
Norwalk, Connecticut 06850
United StatesActive - Recruiting
Orlando Health Cancer Institute - Downtown Orlando
Orlando, Florida 32806
United StatesActive - Recruiting
St. Elizabeth Healthcare - Edgewood
Edgewood, Kentucky 41017
United StatesActive - Recruiting
Trials365, LLC
Shreveport, Louisiana 71103
United StatesActive - Recruiting
Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
Shreveport, Louisiana 71103
United StatesActive - Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Center of Hope
Reno, Nevada 89511
United StatesActive - Recruiting
Holy Name Medical Center
Teaneck, New Jersey 07666
United StatesActive - Recruiting
Perlmutter Cancer Center - 38th Street
New York, New York 10016
United StatesActive - Recruiting
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
New York, New York 10016
United StatesActive - Recruiting
Duke Cancer Institute
Durham, North Carolina 27705
United StatesActive - Recruiting
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina 28374
United StatesActive - Recruiting
JamesCare Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United StatesActive - Recruiting
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
Portland, Oregon 97227
United StatesActive - Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
Abilene, Texas 79606
United StatesActive - Recruiting
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
Austin, Texas 78731
United StatesActive - Recruiting
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
Fort Worth, Texas 76104
United StatesActive - Recruiting
USOR - Virginia Oncology Associates - Norfolk
Norfolk, Virginia 23502
United StatesActive - Recruiting
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