Phase
Condition
Fallopian Tube Cancer
Ovarian Cysts
Treatment
Pegylated Liposomal Doxorubicin (PLD)
Topotecan
MORAb-202
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female participants with histologically-confirmed diagnosis of HGS ovarian, primaryperitoneal, or fallopian tube cancer.
Platinum-resistant disease, defined as:
For participants who had only 1 line of platinum-based therapy: progression between > 1 month and ≤ 6 months after the last dose of platinum-based therapy of at least 4cycles.
For participants who had 2 or 3 lines of platinum-based therapy: progression ≤ 6months after the last dose of platinum-based therapy.
Participants have received at least 1 but no more than 3 prior lines of systemictherapy and for whom single-agent therapy is appropriate as the next line oftherapy. Participants may have been treated with up to 1 line of therapy subsequentto determination of platinum-resistance.
Disease progression per RECIST v1.1 (by investigator assessment) of at least 1measurable lesion on or after the most recent therapy.
Either formalin-fixed, paraffin-embedded (FFPE) tissue (up to 5 years old) ornewly-obtained biopsies must be available for FRα assessment prior to randomization.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Exclusion
Exclusion Criteria:
Medical Conditions
Clear cell, mucinous, endometrioid or sarcomatous histology, or mixed tumorscontaining components of any of these histologies, or low grade or borderlineovarian cancer.
Primary platinum-refractory ovarian cancer defined as disease progression within 1month of the last dose of the first line platinum-containing regimen.
Pulmonary function test (PFT) abnormalities: FEV1 < 70% or FVC < 60%, and DLCO < 80%.
Investigator-assessed current ILD/pneumonitis, or ILD/pneumonitis suspected atscreening or history of ILD/pneumonitis of any severity including ILD/pneumonitisfrom prior anti-cancer therapy.
Significant third-space fluid retention (eg, ascites or pleural effusion) thatrequires repeated drainage.
Physical and Laboratory Test Findings
- Evidence of organ dysfunction or any clinically-significant deviation from normal inphysical examination, vital signs, ECG, or clinical laboratory determinations beyondwhat is consistent with the target population.
Allergies and Adverse Drug Reactions
Has any prior severe hypersensitivity (≥ Grade 3) to monoclonal antibodies oreribulin or contraindication to the receipt of corticosteroids or any of theexcipients (investigators should refer to the prescribing information for theselected corticosteroid).
History of allergy or contraindication to IC chemotherapy agent selected ifrandomized to Arm C.
Other protocol-defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
GenesisCare - North Shore
Sydney, New South Wales 2065
AustraliaActive - Recruiting
Local Institution - 0016
Sydney, New South Wales 2065
AustraliaSite Not Available
Calvary Mater Newcastle
Waratah, New South Wales 2298
AustraliaActive - Recruiting
Local Institution - 0017
Waratah, New South Wales 2298
AustraliaSite Not Available
Icon Cancer Centre - Chermside
Chermside, Queensland 4032
AustraliaSite Not Available
Local Institution - 0031
Chermside, Queensland 4032
AustraliaSite Not Available
Local Institution - 0015
Clayton, Victoria 3168
AustraliaSite Not Available
Monash Medical Centre Clayton
Clayton, Victoria 3168
AustraliaActive - Recruiting
Cabrini Hospital - Malvern
Malvern, Victoria 3144
AustraliaSite Not Available
Local Institution - 0027
Malvern, Victoria 3144
AustraliaSite Not Available
Local Institution - 0027
Melbourne, Victoria 3144
AustraliaSite Not Available
Local Institution - 0058
Nedlands, Western Australia 6009
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
Local Institution - 0075
Perth, Western Australia 6009
AustraliaSite Not Available
Sir Charles Gairdner Hospital (SCGH) - WA Cancer Centre
Perth, Western Australia 6009
AustraliaSite Not Available
Local Institution - 0032
Leuven, VBR 3000
BelgiumSite Not Available
Local Institution - 0013
Namur, WNA 5000
BelgiumSite Not Available
Local Institution - 0012
Brussels, 1200
BelgiumSite Not Available
Local Institution - 0012
Bruxelles, 1200
BelgiumSite Not Available
Local Institution - 0033
Hasselt, 3500
BelgiumSite Not Available
Local Institution - 0045
Liège, 4000
BelgiumSite Not Available
Local Institution - 0059
Santiago, Metropolitana 8420383
ChileSite Not Available
Local Institution - 0030
Santiago, RM 8420323
ChileSite Not Available
Local Institution - 0071
Vina Del Mar, Valparaiso 2540402
ChileSite Not Available
Local Institution - 0060
Vina del Mar, Valparaiso 2540402
ChileSite Not Available
Local Institution - 0036
Santiago, 7510032
ChileSite Not Available
Oncovida - Santiago
Santiago, 7510032
ChileSite Not Available
Local Institution - 0029
Temuco, 4800827
ChileSite Not Available
Local Institution - 0046
Jerusaelm, JM 9112001
IsraelSite Not Available
Local Institution - 0047
Tel-Aviv, Tel Aviv 64239
IsraelSite Not Available
Local Institution - 0054
Haifa, 31999
IsraelSite Not Available
Local Institution - 0046
Jerusalem, 9112001
IsraelSite Not Available
Local Institution - 0080
Jerusalem, 91031
IsraelSite Not Available
Local Institution - 0055
Ramat Gan, 5265601
IsraelSite Not Available
The Chaim Sheba Medical Centre - Division of Oncology
Ramat Gan, 5265601
IsraelSite Not Available
Local Institution - 0048
Tel Aviv-Yafo, 64239
IsraelSite Not Available
Local Institution - 0068
Tel Hashomer, 52621
IsraelSite Not Available
Local Institution - 0048
Tel-Aviv, 64239
IsraelSite Not Available
Local Institution - 0003
Bologna, BO 40138
ItalySite Not Available
Local Institution - 0009
Milano, MI 20141
ItalySite Not Available
Local Institution - 0011
Milano, MI 20132
ItalySite Not Available
Local Institution - 0010
Roma, RM 00168
ItalySite Not Available
Local Institution - 0008
Torino, TO 10126
ItalySite Not Available
Local Institution - 0002
Brescia, 25123
ItalySite Not Available
Local Institution - 0004
Kurume, Fukuoka 8300011
JapanSite Not Available
Local Institution - 0037
Koto-Ku, Tokyo-to 135-8550
JapanSite Not Available
Local Institution - 0079
Akashi, 673-8558
JapanSite Not Available
Hyogo Cancer Center
Akashi, Hyogo, 673-8558
JapanSite Not Available
Local Institution - 0018
Akashi, Hyogo, 673-8558
JapanSite Not Available
Local Institution - 0019
Chuo-Ku, 104-0045
JapanSite Not Available
Local Institution - 0014
Hidaka-shi, 350-1298
JapanSite Not Available
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
JapanActive - Recruiting
Kurume University Hospital
Kurume-Shi, 830-0011
JapanActive - Recruiting
Local Institution - 0004
Kurume-Shi, 830-0011
JapanSite Not Available
Local Institution - 0037
Tokyo, 135-8550
JapanSite Not Available
The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR)
Tokyo, 135-8550
JapanActive - Recruiting
Local Institution - 0064
Goyang-si, 10408
Korea, Republic ofSite Not Available
Local Institution - 0074
Goyang-si, 10408
Korea, Republic ofSite Not Available
Local Institution - 0069
Jongno -Gu, 110-744
Korea, Republic ofSite Not Available
Seoul National University Hospital
Jongno -Gu, 110-744
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 5505
Korea, Republic ofActive - Recruiting
Asan Medical Center (AMC)
Seoul, 5505
Korea, Republic ofActive - Recruiting
Local Institution - 0049
Seoul, 03722
Korea, Republic ofSite Not Available
Local Institution - 0053
Seoul, 5505
Korea, Republic ofSite Not Available
Local Institution - 0056
Seoul, 03080
Korea, Republic ofSite Not Available
Local Institution - 0057
Seoul, 06351
Korea, Republic ofSite Not Available
Local Institution - 0066
Seoul, 135-710
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Yonsei University Health System, Severance Hospital
Seoul, 03722
Korea, Republic ofActive - Recruiting
Local Institution - 0039
Barcelona, B 08035
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, M 28007
SpainSite Not Available
Local Institution - 0001
Madrid, M 28041
SpainSite Not Available
Local Institution - 0005
Madrid, M 28007
SpainSite Not Available
Instituto de Investigacion Sanitaria - Institute of Health Research Hospital Clinic of Valencia
Valencia, V 46010
SpainActive - Recruiting
Local Institution - 0006
Valencia, V 46010
SpainSite Not Available
Local Institution - 0007
Valencia, V 46009
SpainSite Not Available
Local Institution - 0021
Barcelona, 08036
SpainSite Not Available
Local Institution - 0020
Girona, 17007
SpainSite Not Available
Local Institution - 0022
Madrid, 28046
SpainSite Not Available
Local Institution - 0038
Madrid, 28033
SpainSite Not Available
Local Institution - 0040
Orange, California 92868
United StatesSite Not Available
University of California Irvine
Orange, California 92868
United StatesSite Not Available
Local Institution - 0065
Sacramento, California 95817
United StatesSite Not Available
UC Davis Comprehensive Cancer Center
Sacramento, California 95817-1514
United StatesSite Not Available
California Pacific Medical Center (CPMC) - Research Institute
San Francisco, California 94109
United StatesSite Not Available
California Pacific Medical Center - Van Ness Campus Medical Office Building
San Francisco, California 94109-6978
United StatesSite Not Available
Local Institution - 0025
San Francisco, California 94109
United StatesSite Not Available
Local Institution - 0078
Whittier, California 90602-3171
United StatesSite Not Available
The Oncology Institute of Hope and Innovation - Whittier
Whittier, California 90602-3171
United StatesActive - Recruiting
Local Institution - 0051
Aurora, Colorado 80045-2517
United StatesSite Not Available
University of Colorado Denver - Anschutz Medical Campus
Aurora, Colorado 80045-2517
United StatesSite Not Available
Local Institution - 0024
Gainesville, Florida 32611
United StatesSite Not Available
UF Health Endoscopy Center
Gainesville, Florida 32611
United StatesSite Not Available
Local Institution - 0052
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60208
United StatesSite Not Available
Local Institution - 0081
South Bend, Indiana 46601-1033
United StatesSite Not Available
Memorial Hospital of South Bend
South Bend, Indiana 46601
United StatesActive - Recruiting
Local Institution - 0043
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion
Kansas City, Kansas 66160
United StatesActive - Recruiting
University Of Kansas Medical Center
Westwood, Kansas 66205-2003
United StatesSite Not Available
Corewell Health
Grand Rapids, Michigan 49503-2560
United StatesSite Not Available
Local Institution - 0041
Grand Rapids, Michigan 49503
United StatesSite Not Available
Spectrum Health Hospitals
Grand Rapids, Michigan 49503
United StatesSite Not Available
Local Institution - 0034
Saint Louis, Missouri 63110-1010
United StatesSite Not Available
Local Institution - 0035
Bronx, New York 10467-2836
United StatesSite Not Available
Local Institution - 0067
Bronx, New York 10467
United StatesSite Not Available
Columbia University Medical Center - Herbert Irving Pavilion Location
New York, New York 10032-3729
United StatesSite Not Available
Local Institution - 0026
New York, New York 10065-6007
United StatesSite Not Available
Local Institution - 0062
New York, New York 10032
United StatesSite Not Available
Local Institution - 0063
New York, New York 10016
United StatesSite Not Available
Local Institution - 0073
New York, New York 10016-6402
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065-6007
United StatesSite Not Available
Local Institution - 0028
Chapel Hill, North Carolina 27599
United StatesSite Not Available
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Aultman Hospital
Canton, Ohio 44710-1702
United StatesCompleted
Local Institution - 0023
Canton, Ohio 44710-1702
United StatesSite Not Available
Local Institution - 0061
Columbus, Ohio 43219
United StatesSite Not Available
Local Institution - 0076
Columbus, Ohio 43219
United StatesSite Not Available
Zangmeister Cancer Center
Columbus, Ohio 43219
United StatesSite Not Available
Local Institution - 0044
Nashville, Tennessee 37203-1625
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 37203-1625
United StatesSite Not Available
Sarah Cannon Research Institute - Tennessee Oncology
Nashville, Tennessee 37203-1625
United StatesActive - Recruiting
Local Institution - 0050
Dallas, Texas 75235-7320
United StatesSite Not Available
UT Southwestern-Harold C. Simmons Cancer Center
Dallas, Texas 75235-7320
United StatesSite Not Available
University Of Texas Southwestern Medical Center
Dallas, Texas 75235-7320
United StatesSite Not Available
Local Institution - 0082
Salt Lake City, Utah 84124
United StatesSite Not Available
Utah Cancer Specialists
Salt Lake City, Utah 84124
United StatesSite Not Available
Providence Sacred Heart Medical Center & Children's Hospital
Seattle, Washington 98124-5143
United StatesSite Not Available
Local Institution - 0042
Spokane, Washington 99204
United StatesSite Not Available
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington 99204
United StatesSite Not Available
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204-2307
United StatesSite Not Available
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