A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Breast Neoplasms, Lobular Carcinoma, Triple-negative Breast Cancer, Pancreatic Adenocarcinoma
Both
Melanoma, Breast Neoplasms, Lobular Carcinoma, Triple-negative Breast Cancer, Pancreatic Adenocarcinoma
Trial Information
A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands
Inclusion Criteria:
- Patients with melanoma (except uveal), breast cancer (lobular or triple-negative), or
pancreatic adenocarcinoma that has progressed despite standard therapy or for which
no effective standard therapy exists
- Site of disease that can be biopsied
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose of LGK974 in patients treated daily
Outcome Time Frame:
12 months
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CLGK974X2101
NCT ID:
NCT01351103
Start Date:
December 2011
Completion Date:
August 2014
Related Keywords:
- Melanoma
- Breast Neoplasms
- Lobular Carcinoma
- Triple-negative Breast Cancer
- Pancreatic Adenocarcinoma
- LGK974
- Melanoma
- Breast neoplasms
- lobular carcinoma
- triple-negative breast cancer
- pancreatic adenocarcinoma
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Breast Neoplasms
- Neoplasms
- Carcinoma
- Melanoma
- Carcinoma, Lobular
Name | Location |
|---|---|
| Dana Farber Cancer Institute SC | Boston, Massachusetts 02115 |
| The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins | Baltimore, Maryland 21231 |
| Wayne State University/Karmanos Cancer Institute Wayne St | Detroit, Michigan 48201 |
| MD Anderson Cancer Center/University of Texas MD Anderson 2 | Houston, Texas 77030-4009 |
