Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Disorders
Urologic Cancer
Treatment
ABBV-969
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histological, pathological, and/or cytological confirmation of adenocarcinoma of theprostate.
Estimated life expectancy > 6 months.
Must have progressed on prior novel hormonal agents (NHAs) (e.g., abirateroneacetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/orcastration-resistant prostate cancer (CRPC). Determination of progression is doneper local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3).
Serum testosterone levels <= 50 ng/dL (<= 1.73 nmol/L) within the screening periodand prior to the first dose of the study drug.
Must have received at least one NHA (e.g., enzalutamide and/or abiraterone).Additionally, participants must have received at least one taxane for prostatecancer (or have refused, or are intolerant to, or unable to get access to taxanes).
Must have >= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <= 28 daysprior to beginning study therapy.
Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.
Availability of representative baseline tumor tissue (most recent archived tumortissue after any novel hormonal agent (NHA) and/or any Prostate-Specific MembraneAntigen (PSMA) targeted therapy or fresh biopsy collected during screening phase)suitable for immunohistochemistry (IHC) testing. This requirement may be waived atthe discretion of the AbbVie Medical Monitor if collecting a biopsy at screeningwould place the subject at risk of harm or would require a technically complicatedprocedure based on tumor location as assessed by the investigator.
Laboratory values meeting the criteria laid out in the protocol.
QT interval corrected for heart rate (QTc) <= 470 msec (using Fridericia'scorrection), no >= Grade 3 arrythmia, and no other clinically significant cardiacabnormalities.
Exclusion
Exclusion Criteria:
Unresolved Grade 2 or higher toxicities related to previous anticancer therapyexcept alopecia.
History of other active malignancy, as laid out in the protocol.
History of interstitial lung disease (ILD) or pneumonitis that required treatmentwith systemic steroids, nor any evidence of active ILD or pneumonitis on screeningchest CT scan.
History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
History of or active clinically significant, intercurrent lung-specific illnessesincluding, but not limited to those listed in the protocol.
Study Design
Connect with a study center
Chris O'Brien Lifehouse /ID# 261731
Camperdown, New South Wales 2050
AustraliaSite Not Available
Chris O'Brien Lifehouse /ID# 261731
Camperdown 2172563, New South Wales 2155400 2050
AustraliaActive - Recruiting
Ballarat Base Hospital /ID# 264294
Ballarat, Victoria 3350
AustraliaSite Not Available
St Vincent's Hospital /ID# 264293
Fitzroy, Victoria 3065
AustraliaSite Not Available
Ballarat Base Hospital /ID# 264294
Ballarat 2177091, Victoria 2145234 3350
AustraliaActive - Recruiting
St Vincent's Hospital /ID# 264293
Fitzroy 2166584, Victoria 2145234 3065
AustraliaActive - Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM) /ID# 270890
Montreal 6077243, Quebec 6115047 H2X 0C1
CanadaActive - Recruiting
Centre Oscar Lambret /ID# 270602
Lille 2998324, Nord 59000
FranceActive - Recruiting
Centre Leon Berard /ID# 270605
Lyon 2996944, Rhone 69373
FranceActive - Recruiting
Institut Gustave Roussy /ID# 270603
Villejuif 2968705, Île-de-France Region 3012874 94800
FranceActive - Recruiting
The Chaim Sheba Medical Center /ID# 261772
Ramat Gan 293788, Tel Aviv 293396 5265601
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 261772
Ramat Gan, Tel-Aviv 5265601
IsraelSite Not Available
Rambam Health Care Campus /ID# 261770
Haifa, 3525408
IsraelSite Not Available
Rambam Health Care Campus /ID# 261770
Haifa 294801, 3525408
IsraelActive - Recruiting
Hadassah Medical Center-Hebrew University /ID# 261771
Jerusalem, 91120
IsraelSite Not Available
Hadassah Medical Center-Hebrew University /ID# 261771
Jerusalem 281184, 91120
IsraelActive - Recruiting
National Cancer Center Hospital East /ID# 261606
Kashiwa-shi, Chiba 2113014 277-8577
JapanActive - Recruiting
Kyoto University Hospital /ID# 261861
Kyoto-shi, Kyoto 606-8507
JapanSite Not Available
Kyoto University Hospital /ID# 261861
Kyoto 1857910, Kyoto 1857907 606-8507
JapanActive - Recruiting
National Cancer Center Hospital /ID# 261698
Chuo-ku, Tokyo 1850144 104-0045
JapanActive - Recruiting
Hospital Universitario Vall de Hebron /ID# 270889
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro /ID# 271345
Madrid 3117735, 28050
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio /ID# 270617
Seville 2510911, 41013
SpainActive - Recruiting
City of Hope /ID# 262059
Duarte, California 91010
United StatesSite Not Available
Univ California, San Francisco /ID# 261715
San Francisco, California 94143-2204
United StatesSite Not Available
City of Hope /ID# 262059
Duarte 5344147, California 5332921 91010
United StatesActive - Recruiting
Univ California, San Francisco /ID# 261715
San Francisco 5391959, California 5332921 94143-2204
United StatesActive - Recruiting
Yale University School of Medicine /ID# 262234
New Haven, Connecticut 06510
United StatesSite Not Available
Yale University School of Medicine /ID# 262234
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
AdventHealth Orlando /ID# 261686
Orlando, Florida 32803
United StatesSite Not Available
AdventHealth Orlando /ID# 261686
Orlando 4167147, Florida 4155751 32803
United StatesActive - Recruiting
The University of Chicago Medical Center /ID# 261605
Chicago, Illinois 60637-1443
United StatesActive - Recruiting
University of Chicago Medical Center /ID# 261605
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago Medical Center /ID# 261605
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
START Midwest /ID# 264295
Grand Rapids, Michigan 49546
United StatesSite Not Available
START Midwest /ID# 264295
Grand Rapids 4994358, Michigan 5001836 49546
United StatesActive - Recruiting
Carolina BioOncology Institute /ID# 261602
Huntersville, North Carolina 28078
United StatesSite Not Available
Carolina BioOncology Institute /ID# 261602
Huntersville 4472370, North Carolina 4482348 28078
United StatesActive - Recruiting
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Providence, Rhode Island 02903-4923
United StatesSite Not Available
Lifespan Cancer Institute at Rhode Island Hospital /ID# 261687
Providence 5224151, Rhode Island 5224323 02903-4923
United StatesActive - Recruiting
NEXT Oncology /ID# 261601
San Antonio, Texas 78229
United StatesSite Not Available
NEXT Oncology /ID# 261601
San Antonio 4726206, Texas 4736286 78229
United StatesActive - Recruiting

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