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A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands
Conditions
Pancreatic Adenocarcinoma - BRAF Mutant Colorectal Cancer - Other Tumor Types With Documented Genetic Alterations Upstream in the Wnt Signaling Pathway
Conditions: official terms
Adenocarcinoma - Colorectal Neoplasms
Conditions: Keywords
LGK974, pancreatic adenocarcinoma, BRAF mutant colorectal cancer, other tumor types with documented genetic alterations upstream in the Wnt signaling pathway
Study Type
Interventional
Study Phase
Phase 1
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LGK974
Type: Drug
Overall Status
Recruiting
Summary
This primary purpose of this study is to find the recommended dose of LGK974 that can be safely given to adult patients with maliganacies dependent on Wnt ligands for whom no effective standard treatment is available.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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:
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.
Dose expansion part: documented B-RAF mutant colorectal cancer with documented Wnt pathway alteration or pancreatic adenocarcinoma with documented Wnt pathway alteration. In addition, patients with tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway are eligible with prior agreement with Novartis
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
Other protocol-defined inclusion/exclusion criteria may apply
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:
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.
Dose expansion part: documented B-RAF mutant colorectal cancer with documented Wnt pathway alteration or pancreatic adenocarcinoma with documented Wnt pathway alteration. In addition, patients with tumors of any histological origin with documented genetic alterations upstream in the Wnt signaling pathway are eligible with prior agreement with Novartis
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
Other protocol-defined inclusion/exclusion criteria may apply
Locations
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins
Baltimore, Maryland, United States
Dana Farber Cancer Institute SC
Status: Recruiting
Contact: Kathy Elza-Brown - 410-502-2377 - kelzabr1@jhmi.edu
Boston, Massachusetts, United States
Dana Farber Cancer Institute SC-7
Status: Withdrawn
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Onc Dept.
Status: Not yet recruiting
Contact: Dennise Greensmith - 617-632-6308 - dgreensmith@mgh.harvard.edu
Ann Arbor, Michigan, United States
Karmanos Cancer Institute Wayne St
Status: Not yet recruiting
Contact: Suzanne Miesterfeld - 734-232-0753 - miestes@med.umich.edu
Detroit, Michigan, United States
University of Texas/MD Anderson Cancer Center MD Anderson 2
Status: Recruiting
Contact: Sarah Bigelow - 313-576-8096 - bigelows@karmanos.org
Houston, Texas, United States
Novartis Investigative Site
Status: Recruiting
Contact: Stepanek M. Vanda - 713-792-2921 - vstepane@mdanderson.org
Rotterdam, Netherlands
Novartis Investigative Site
Status: Recruiting
Barcelona, Catalunya, Spain
Novartis Investigative Site
Status: Recruiting
Madrid, Spain
Status: Not yet recruiting
Start Date
December 2011
Completion Date
January 2017
Sponsors
Novartis Pharmaceuticals
Source
Novartis
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page