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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
Open (Enrolling)
Both
Melanoma, Breast Neoplasms, Lobular Carcinoma, Triple-negative Breast Cancer, Pancreatic Adenocarcinoma

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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 SCBoston, Massachusetts  02115
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns HopkinsBaltimore, Maryland  21231
Wayne State University/Karmanos Cancer Institute Wayne StDetroit, Michigan  48201
MD Anderson Cancer Center/University of Texas MD Anderson 2Houston, Texas  77030-4009