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NCT01487785 · ClinicalTrials.gov registry record · Phase 1
Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients
A Phase 1 study of Pancreatic Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 5
- Study locations
NCT01487785: Completed Phase 1 study of Pancreatic Cancer, sponsored by Novartis Pharmaceuticals.
NCT01487785 is a Phase 1 study of Pancreatic Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 18 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01487785, a Phase 1 study of Pancreatic Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase Ib study includes two phases: dose escalation phase and safety expansion phase. During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once daily (QD) dose in combination of gemcitabine. This phase of the study will determine the maximum tolerated dose (MTD) and/ or recommended dose for expansion (RDE) of LDE225 administered in combination with gemcitabine in locally advanced or metastatic pancreatic adenocarcinoma patients. During the safety expansion phase, once the MTD of LDE225 is established, additional patients will be enrolled and treated at the MTD of LDE225 in combination with gemcitabine in order to further evaluate its safety, tolerability and explore the potential efficacy of the combined treatments on the patients in locally advanced or metastatic pancreatic adenocarcinoma.
Primary Outcome
Dose limiting toxicities that occur during the first 8 weeks (56 days) of treatment with LDE225+gemcitabine. Dose limiting toxicity is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications that meets study specific criteria.
Conditions Studied
Interventions
- DRUG LDE225+gemcitabine
Study Locations (5)
Massachusetts
- Massachusetts General Hospital Dept. of Mass General Hospital - Boston
New York
- Memorial Sloan Kettering Cancer Center MSKCC - SC - New York
Utah
- University of Utah / Huntsman Cancer Institute Huntsman UT - Salt Lake City
Catalonia
- Novartis Investigative Site - Barcelona
Other
- Novartis Investigative Site - Liverpool
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 1 |
What the finished NCT01487785 record still lists
NCT01487785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which LDE225+gemcitabine is the first listed.
NCT01487785 lists 5 locations in 5 states (Massachusetts, New York, Utah).
Frequently Asked Questions
What is clinical trial NCT01487785 about?
NCT01487785 is a clinical study titled "Dose-escalation, and Safety Study of LDE225 and Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer Patients". This phase Ib study includes two phases: dose escalation phase and safety expansion phase. During the dose escalation phase, successive cohorts of eligible patients (minimum 3 and maximum 6 evaluable patients per cohort) will receive increasing oral doses of LDE225 administered on a continuous once...
What is the current status of trial NCT01487785?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2012-03. Estimated completion is 2014-07.
What conditions does trial NCT01487785 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT01487785?
The interventions under investigation include: LDE225+gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01487785?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01487785 being conducted?
This trial has 5 study locations across Massachusetts, New York, Utah, Catalonia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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