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
Locations
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins
Baltimore, Maryland, United States
Status: Recruiting
Contact: Kathy Elza-Brown - 410-502-2377 - kelzabr1@jhmi.edu
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States
Status: Withdrawn
Dana Farber Cancer Institute SC-7
Boston, Massachusetts, United States
Status: Not yet recruiting
Contact: Dennise Greensmith - 617-632-6308 - dgreensmith@mgh.harvard.edu
University of Michigan Comprehensive Cancer Center Onc Dept.
Ann Arbor, Michigan, United States
Status: Not yet recruiting
Contact: Suzanne Miesterfeld - 734-232-0753 - miestes@med.umich.edu
Karmanos Cancer Institute Wayne St
Detroit, Michigan, United States
Status: Recruiting
Contact: Sarah Bigelow - 313-576-8096 - bigelows@karmanos.org
University of Texas/MD Anderson Cancer Center MD Anderson 2
Houston, Texas, United States
Status: Recruiting
Contact: Stepanek M. Vanda - 713-792-2921 - vstepane@mdanderson.org
Novartis Investigative Site
Rotterdam, Netherlands
Status: Recruiting
Novartis Investigative Site
Barcelona, Catalunya, Spain
Status: Recruiting
Novartis Investigative Site
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