A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands
NCT ID: NCT01351103
Last Updated: 2025-06-13
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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COMPLETED
PHASE1
185 participants
INTERVENTIONAL
2011-12-01
2024-06-17
Brief Summary
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Detailed Description
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The study comprised of 2 parts: a dose escalation of LGK974 as a single agent, followed by a safety expansion in specific disease indications; and a dose escalation of LGK974 in combination with PDR001, followed by a safety expansion in cutaneous melanoma.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LGK974
LGK974
LGK974
LGK974 in combination with PDR001
LGK in combination with PDR001
LGK974
PDR001
Interventions
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LGK974
PDR001
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Single Agent Dose escalation part:documented B-RAF mutant colorectal cancer or pancreatic adenocarcinoma. In addition, tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway are eligible with prior agreement with Novartis.
Single Agent Dose expansion part: documented B-RAF mutant colorectal cancer with documented RNF43 mutation and/or RSPO fusion or pancreatic adenocarcinoma with documented RNF43 mutation. In addition, patients with tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway (e.g. RNF43 or RSPO fusion) are eligible with prior agreement with Novartis
LGK974 with PDR001: Dose escalation: patients with the following cancers that were previously treated with anti-PD-1 therapy and whose best response on that therapy was progressive disease (i.e. primary refractory): melanoma, lung SCC, HNSCC. Patients with esophageal SCC, cervical SCC or TNBC who are either naïve or primary refractory to prior anti-PD-1 therapy.
LGK974 with PDR001: Dose expansion: patients with:
* cutaneous melanoma that was primary refractory to prior anti-PD-1 therapy, defined as a best response of progressive disease or stable disease for \<= 4 months, or disease recurrence with the first 6 months of adjuvant therapy. Patients with BRAF V600-mutant melanoma must have also received and been failed by prior systemic therapy with BRAF V600 inhibitor, with or without a MEK inhibitor.
* Cutaneous melanoma with acquired resistance to prior anti-PD-1 therapy, defined as progressive disease following response (PR or CR) or following stable disease for \> 4 months. Patients with BRAF V600-mutant melanoma must have also received and been failed by prior systemic therapy with a BRAF V600 inhibitor, with or without a MEK inhibitor.
Exclusion Criteria
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LGK974 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
* Brain metastases that have not been adequately treated
* Malignant disease other than that being treated in this study
* Laboratory abnormalities as specified in the protocol
* Osteoporosis, osteopenia
* Bone fractures within the past year
* Pathologic bone fracture
* Active, known or suspected autoimmune disease or severe hypersensitivity reactions to other monoclonal antibodies
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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UCLA School of Medicine
Los Angeles, California, United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute SC-7
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Onc Dept.
Ann Arbor, Michigan, United States
Karmanos Cancer Institute Wayne St
Detroit, Michigan, United States
University of Texas/MD Anderson Cancer Center MD Anderson 2
Houston, Texas, United States
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Villejuif, , France
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Rotterdam, South Holland, Netherlands
Novartis Investigative Site
Utrecht, , Netherlands
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Madrid, , Spain
Countries
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References
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Rodon J, Argiles G, Connolly RM, Vaishampayan U, de Jonge M, Garralda E, Giannakis M, Smith DC, Dobson JR, McLaughlin ME, Seroutou A, Ji Y, Morawiak J, Moody SE, Janku F. Phase 1 study of single-agent WNT974, a first-in-class Porcupine inhibitor, in patients with advanced solid tumours. Br J Cancer. 2021 Jul;125(1):28-37. doi: 10.1038/s41416-021-01389-8. Epub 2021 May 3.
Related Links
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Link to Study Results
Other Identifiers
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2011-000495-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLGK974X2101
Identifier Type: -
Identifier Source: org_study_id
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