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NCT01351103 · ClinicalTrials.gov registry record · Phase 1
A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands
A Phase 1 study of Pancreatic Cancer and Melanoma, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 185
- Enrollment target
- 20
- Study locations
NCT01351103: Completed Phase 1 study of Pancreatic Cancer and Melanoma, sponsored by Novartis Pharmaceuticals.
NCT01351103 is a Phase 1 study of Pancreatic Cancer and Melanoma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 185 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01351103, a Phase 1 study of Pancreatic Cancer and Melanoma, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 185 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
DLT is defined as an adverse event or abnormal laboratory value that is assessed by the investigator as unrelated to disease, disease progression, intercurrent illness, or concomitant medications and that meets the criteria defined in the study protocol. The objective was to determine the Maximum Tolerated Dose (MTD) or Recommended Dose for Expansion (RDE) of LGK974 as a single agent and in combination with PDR001 when administered orally to adult patients with malignancies dependent on Wnt lig
Conditions Studied
Interventions
- DRUG LGK974
- BIOLOGICAL PDR001
Study Locations (20)
Other
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Naples
- Novartis Investigative Site - Utrecht
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Madrid
- Novartis Investigative Site - Madrid
Catalonia
- Novartis Investigative Site - Barcelona
- Novartis Investigative Site - Barcelona
- Novartis Investigative Site - L'Hospitalet de Llobregat
Michigan
- University of Michigan Comprehensive Cancer Center Onc Dept. - Ann Arbor
- Karmanos Cancer Institute Wayne St - Detroit
California
- UCLA School of Medicine - Los Angeles
Maryland
- Sidney Kimmel Comprehensive Cancer Center Johns Hopkins - Baltimore
Massachusetts
- Dana Farber Cancer Institute SC-7 - Boston
Texas
- University of Texas/MD Anderson Cancer Center MD Anderson 2 - Houston
Quebec
- Novartis Investigative Site - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2011-12-01 |
| Est. Completion | 2024-06-17 |
| Phase | Phase 1 |
What the finished NCT01351103 record still lists
NCT01351103 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (53% lower).
The record links to 8 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which LGK974 is the first listed.
NCT01351103 names 20 study sites across 11 states, led by Other, Catalonia, Michigan.
Frequently Asked Questions
What is clinical trial NCT01351103 about?
NCT01351103 is a clinical study titled "A Study of LGK974 in Patients With Malignancies Dependent on Wnt Ligands". 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.
What is the current status of trial NCT01351103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 185 participants. The study started on 2011-12-01. Estimated completion is 2024-06-17.
What conditions does trial NCT01351103 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Melanoma, Triple Negative Breast Cancer, Head and Neck Squamous Cell Cancer, Esophageal Squamous Cell Cancer.
What interventions are being tested in trial NCT01351103?
The interventions under investigation include: LGK974 (DRUG), PDR001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01351103?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01351103 being conducted?
This trial has 20 study locations across California, Maryland, Massachusetts, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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