Trials / Completed
CompletedNCT01351103
A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands
A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study was to find the recommended dose of LGK974 as a single agent and in combination with PDR001 that can be safely given to adult patients with selected solid malignancies that had progressed despite standard therapy or for which no effective standard therapy existed.
Detailed description
This open-label multicenter phase 1 dose escalation study was the first to administer LGK974 as a single agent or in combination with PDR001 in humans. The study comprised of 2 parts: a dose escalation of LGK974 as a single agent, followed by a safety expansion in specific disease indications; and a dose escalation of LGK974 in combination with PDR001, followed by a safety expansion in cutaneous melanoma.
Conditions
- Pancreatic Cancer
- BRAF Mutant Colorectal Cancer
- Melanoma
- Triple Negative Breast Cancer
- Head and Neck Squamous Cell Cancer
- Cervical Squamous Cell Cancer
- Esophageal Squamous Cell Cancer
- Lung Squamous Cell Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LGK974 | |
| BIOLOGICAL | PDR001 |
Timeline
- Start date
- 2011-12-01
- Primary completion
- 2021-06-01
- Completion
- 2024-06-17
- First posted
- 2011-05-10
- Last updated
- 2025-06-13
Locations
20 sites across 7 countries: United States, Canada, France, Germany, Italy, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01351103. Inclusion in this directory is not an endorsement.