A Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands
This study is currently recruiting participants.
Verified November 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01351103
First received: May 4, 2011
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
This primary purpose of this study is to find the highest 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma Breast Neoplasms Lobular Carcinoma Triple-negative Breast Cancer Pancreatic Adenocarcinoma |
Drug: LGK974 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Maximum Tolerated Dose of LGK974 in patients treated daily [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Type and category of study drug related adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Absorption and plasma concentrations of LGK974 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Biomarkers related to the Wnt pathway [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Overall response rate of tumor [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LGK974 | Drug: LGK974 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351103
Contacts
| Contact: Novartis Pharmaceuticals | +1(800)340-6843 |
Locations
| United States, Maryland | |
| The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins | Not yet recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Ashley OConnor 410-502-2377 aoconnor@jhmi.edu | |
| Principal Investigator: Roisin Connolly | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute SC | Withdrawn |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Wayne State University/Karmanos Cancer Institute Wayne St | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Angela Powell 313-576-8096 powellan@karmanos.org | |
| Principal Investigator: Patricia M. LoRusso | |
| United States, Texas | |
| MD Anderson Cancer Center/University of Texas MD Anderson 2 | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Shelia Lister 713-792-2921 slister@mdanderson.org | |
| Principal Investigator: Sapna P. Patel | |
| Netherlands | |
| Novartis Investigative Site | Recruiting |
| Rotterdam, Netherlands, 3075 EA | |
| Spain | |
| Novartis Investigative Site | Recruiting |
| Barcelona, Cataluña, Spain, 08035 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01351103 History of Changes |
| Other Study ID Numbers: | CLGK974X2101, 2011-000495-33 |
| Study First Received: | May 4, 2011 |
| Last Updated: | November 13, 2012 |
| Health Authority: | United States: Food and Drug Administration Spain: MINSTERIO DE SANIDAD, POLÍTICA SOCIAL E IGUALDAD Netherlands: Central Committee on Research inv. Human Subjects |
Keywords provided by Novartis:
|
LGK974 Melanoma Breast neoplasms |
lobular carcinoma triple-negative breast cancer pancreatic adenocarcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Breast Neoplasms Neoplasms Carcinoma Melanoma Carcinoma, Lobular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Cystic, Mucinous, and Serous |
Neoplasms by Site Breast Diseases Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 21, 2013