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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000494-32 | EudraCT Number |
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The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast & Prostate Cancer Group | Experimental | Dose Escalation |
|
| Breast Cancer Group | Experimental | Dose Expansion |
|
| Prostate Cancer Group | Experimental | Dose Expansion |
|
| Uterine Leiomyoma Group | Experimental | Dose Expansion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFA102 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Dose Limiting Toxicity | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LFA102 serum concentration | 6 months | |
| Disease response | every 2 to 3 months | |
| Concentrations of antibodies to LFA102 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Mass Gen 3 | Boston | Massachusetts | 02114 | United States | ||
| Cancer Institute of New Jersey SC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27091421 | Derived | Agarwal N, Machiels JP, Suarez C, Lewis N, Higgins M, Wisinski K, Awada A, Maur M, Stein M, Hwang A, Mosher R, Wasserman E, Wu G, Zhang H, Zieba R, Elmeliegy M. Phase I Study of the Prolactin Receptor Antagonist LFA102 in Metastatic Breast and Castration-Resistant Prostate Cancer. Oncologist. 2016 May;21(5):535-6. doi: 10.1634/theoncologist.2015-0502. Epub 2016 Apr 18. |
| Label | URL |
|---|---|
| Results for CLFA102X2102 can be found on the Novartis Clinical Trial Results Website | View source |
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| every month |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Thomas Jefferson University, Dept. of Phsyciatry & Neurology Thomas Jefferson | Philadelphia | Pennsylvania | 19107 | United States |
| University of Utah / Huntsman Cancer Institute Huntsman 3 | Salt Lake City | Utah | 84103 | United States |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | United States |
| Novartis Investigative Site | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Modena | MO | 41100 | Italy |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D047708 | Myofibroma |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D003240 | Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C583731 | LFA102 monoclonal antibody |
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