A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands



Status:Recruiting
Conditions:Breast Cancer, Colorectal Cancer, Skin Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:December 1, 2011
End Date:August 20, 2020
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands

This primary purpose of this study is to find the recommended dose of LGK974 as a single
agent and in combination with PDR001 that can be safely given to adult patients with selected
solid malignancies for whom no effective standard treatment is available.


Inclusion Criteria:

Diagnosis of locally advanced or metastatic cancer that has progressed despite standard
therapy or for which no effective standard therapy exists and histological confirmation of
one of the following diseases indicated below:

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 pancreatic cancer, or TNBC, or melanoma,
or head and neck cancer.

Exclusion Criteria:

- Impaired cardiac function

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of oral 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, severe or untreated osteopenia

- Bone fractures within the past year

- Pathologic bone fracture

- Active, known or suspected autoimmune disease or severe hypersensitivity reactions to
other monoclonal antibodies

Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
8
sites
Boston, Massachusetts 02115
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Ann Arbor, Michigan 48109
Principal Investigator: David Smith
Phone: 800-865-1125
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Ann Arbor, MI
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Baltimore, Maryland 21287
Principal Investigator: Roisin Connolly
Phone: +1 410 502 2377
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Baltimore, MD
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Boston, Massachusetts 02115
Principal Investigator: Marios Giannakis, M.D., Ph.D.
Phone: 617-632-6805
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Boston, MA
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113 West Forest Avenue
Detroit, Michigan 48201
Principal Investigator: Ulka A. Vaishampayan
Phone: 313-576-9371
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Detroit, MI
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Houston, Texas 77030
Principal Investigator: Filip P. Janku
Phone: 713-792-2921
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Houston, TX
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Los Angeles, California 90095
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Los Angeles, CA
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Rotterdam,
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