Phase
Condition
Neoplasms
Solid Tumors
Treatment
Ribociclib
Palbociclib
INCB0123667
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults aged 18 years or older at the time of the signing of the ICF.
Life expectancy greater than 12 weeks.
ECOG performance status score of 0 or 1.
Disease progression on prior standard treatment, intolerance to or ineligibility forstandard treatment, or no available treatment to improve the disease outcome.
Availability of a baseline archival tumor specimen or willingness to undergo apretreatment and an on-treatment tumor biopsy.
For Part 1:
Participants in Part 1A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
Participants in Part 1B (dose expansion):
Disease Group 1: Ovarian/Fallopian/Primary Peritoneal Cancer
Disease Group 2: Endometrial/Uterine Cancer
Disease Group 3: Gastric, GEJ, and esophageal carcinomas
Disease Group 4: TNBC
Disease Group 5: HR+/HER2- breast cancer
Disease Group 6: Other tumor indications excluding bone cancers
For Part 2:
Participants in Part 2A (dose escalation): Histologically or cytologically confirmed advanced or metastatic solid tumors.
TGA, TGC, TGE, TGF, and TGG: Participants with HR+/HER2- breast cancer orparticipants with a different tumor.
TGB and TGD: Participants with HR+/HER2- breast cancer.
Participants in Part 2b (dose expansion):
TGH and TGJ:
Participants with HR+/HER2- breast cancer.
Participants with any other advanced or metastatic solid tumor.
TGI and TGK:
• Participants with HR+/HER2- breast cancer.
- TGL, TGM and TGN:
• Participants with advanced or metastatic epithelial ovarian/fallopian/primaryperitoneal carcinoma.
- Measurable lesions by CT or MRI based on RECIST v1.1 criteria.
Exclusion
Exclusion Criteria:
History of clinically significant or uncontrolled cardiac disease.
History or presence of an ECG abnormality that, in the investigator's opinion, isclinically meaningful.
Presence of chronic or current active infectious disease requiring systemicantibiotic, antifungal, or antiviral treatment.
Untreated brain or central nervous system (CNS) metastases or brain or CNSmetastases that have progressed.
Known additional malignancy that is progressing or requires active treatment, orhistory of other malignancy within 2 years of the first dose of study drug.
Specific laboratory values.
Significant concurrent, uncontrolled medical conditions, including but not limitedto Hepatic and Gastrointestinal.
Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/orcomplications from prior surgical intervention before starting study drug.
Prior treatment with any CDK2 inhibitor.
Any change in endocrine therapy within 5 half-lives or 28 days (whichever isshorter) before the first dose of study drug or any administration of targetedtherapy, antibody, or hypomethylating agent to treat the participant's diseasewithin 5 half-lives or 28 days (whichever is shorter) before the first dose of studydrug.
Any major surgery within 28 days before the first dose of study drug.
Any prior radiation therapy within 28 days before the first dose of study drug.
Undergoing treatment with another investigational medication or having been treatedwith an investigational medication within 5 half-lives or 28 days (whichever isshorter) before the first dose of study drug.
Active HBV or HCV infection that requires treatment.
Known history of HIV.
Known hypersensitivity or severe reaction to any component of study treatment orformulation components.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
Connect with a study center
Institut Bergonie
Bordeaux, 33076
FranceActive - Recruiting
Centre Leon Berard
Lyon, 69373
FranceActive - Recruiting
Institut Curie
Paris, 75005
FranceSite Not Available
Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole
Toulouse, 31059
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif, 94800
FranceSite Not Available
Institut Gustave Roussy
Villejuif Cedex, 94805
FranceActive - Recruiting
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano
Milan, 20133
ItalyActive - Recruiting
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
ItalyActive - Recruiting
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
Milan, 20133
ItalyActive - Recruiting
Istituto Nazionale Tumori Irccs Fondazione Pascale
Naples, 80131
ItalyActive - Recruiting
Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore
Rome, 00168
ItalyActive - Recruiting
Irccs Istituto Clinico Humanitas
Rozzano, 20089
ItalyActive - Recruiting
Centro Ricerche Cliniche Di Verona
Verona, 37134
ItalyActive - Recruiting
Centro Ricerche Cliniche Di Verona (Crc)
Verona, 37134
ItalyActive - Recruiting
Aichi Cancer Center Hospital
Aichi, 464-8681
JapanActive - Recruiting
National Cancer Center Hospital East
Chiba, 277-8577
JapanActive - Recruiting
National Cancer Center Hospital East
Chiba-ken, 277-8577
JapanSite Not Available
Saitama Medical University International Medical Center
Hidaka-shi, 350-1298
JapanActive - Recruiting
The Cancer Institute Hospital of Jfcr
Koto-ku, 135-8550
JapanActive - Recruiting
National Cancer Center Hospital
Tokyo, 104-0045
JapanActive - Recruiting
Netherlands Cancer Institute Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
NetherlandsActive - Recruiting
Erasmus Medical Center
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Panoncology Trials Pan American Center For Oncology Trials, Llc
Rio Piedras, 00935
Puerto RicoActive - Recruiting
Oncological Institute of Southern Switzerland
Bellinzona, 6500
SwitzerlandActive - Recruiting
Inselspital Universitatsklinik Fur Medizinische Onkologie
Bern, 3010
SwitzerlandActive - Recruiting
Centre Hospitalier Universitaire Vaudois (Chuv)
Lausanne, 01011
SwitzerlandActive - Recruiting
Western General Hospital
Edinburgh, EH4 2XU
United KingdomSite Not Available
Guys Hospital
London, SE1 9RT
United KingdomActive - Recruiting
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
London, W12 0HS
United KingdomActive - Recruiting
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV
United KingdomSite Not Available
Northern Centre For Cancer Care
Newcastle Upon Tyne, NE7 7DN
United KingdomActive - Recruiting
City of Hope Medical Center
Duarte, California 91010
United StatesActive - Recruiting
City of Hope-Lennar Foundation Cancer Center
Irvine, California 92618
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06510
United StatesCompleted
Mount Sinai Medical Center Comprehensive Cancer Center
Miami Beach, Florida 33140
United StatesActive - Recruiting
Emory University
Atlanta, Georgia 30322
United StatesActive - Recruiting
University of Kansas Cancer Center
Westwood, Kansas 66205
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
New York Presbyterian/Weill Cornell
New York, New York 10065
United StatesActive - Recruiting
Weill Cornell Breast Center
New York, New York 10065
United StatesSite Not Available
Ny Cancer and Blood Specialists
Shirley, New York 11967
United StatesSite Not Available
Carolina Bio-Oncology Institute, Pllc
Huntersville, North Carolina 28078
United StatesCompleted
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37203
United StatesSite Not Available
Texas Oncology
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology-Fort Worth South Henderson
Fort Worth, Texas 76104
United StatesActive - Recruiting
Virginia Cancer Institute
Fairfax, Virginia 22031
United StatesSite Not Available
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
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