Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers
NCT ID: NCT02734615
Last Updated: 2022-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
199 participants
INTERVENTIONAL
2016-06-14
2021-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Patients will get LSZ102 single agent during dose escalation.
LSZ102
LSZ102
Arm B
Patients will get LSZ102 in combination with LEE011 during dose escalation.
LSZ102
LSZ102
LEE011
LEE011
Arm C
Patients will get LSZ102 in combination with BYL719 during dose escalation.
LSZ102
LSZ102
BYL719
BYL719
Arm 1
Patients will get LSZ102 single agent during dose expansion
LSZ102
LSZ102
Arm 2
Patients will get LSZ102 + LEE011 (LEE011 intermittent regimen) during dose expansion
LSZ102
LSZ102
LEE011
LEE011
Arm 3
Patients will get LSZ102 + LEE011 (LEE011 continuous regimen) during dose expansion
LSZ102
LSZ102
LEE011
LEE011
Arm 4
Patient will get LSZ102 in combination with BYL719 during dose expansion
LSZ102
LSZ102
BYL719
BYL719
Interventions
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LSZ102
LSZ102
LEE011
LEE011
BYL719
BYL719
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically and/or cytologically confirmed diagnosis of ER+/HER2- breast cancer
* Advanced or metastatic breast cancer
* Must be able to swallow tablets and capsules
Exclusion Criteria
* Patients whose laboratory values do not meet protocol criteria
* Clinically significant cardiac disease
* Impaired gastrointestinal function (GI) or GI disease that may significantly alter the absorption of oral medications
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Massachusetts General Hospital Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center SC - LSZ102X2101
Houston, Texas, United States
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
Singapore, , Singapore
Countries
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References
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Jhaveri K, Juric D, Yap YS, Cresta S, Layman RM, Duhoux FP, Terret C, Takahashi S, Huober J, Kundamal N, Sheng Q, Balbin A, Ji Y, He W, Crystal A, De Vita S, Curigliano G. A Phase I Study of LSZ102, an Oral Selective Estrogen Receptor Degrader, with or without Ribociclib or Alpelisib, in Patients with Estrogen Receptor-Positive Breast Cancer. Clin Cancer Res. 2021 Nov 1;27(21):5760-5770. doi: 10.1158/1078-0432.CCR-21-1095. Epub 2021 Aug 25.
Related Links
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Other Identifiers
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2015-004016-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLSZ102X2101
Identifier Type: -
Identifier Source: org_study_id
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