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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 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.

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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.

Conditions Studied

Pancreatic Cancer

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

FieldValue
Enrollment Target 18 participants
Start Date 2012-03
Est. Completion 2014-07
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT01487785

The ClinicalTrials.gov registry entry for NCT01487785 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 5 study locations spanning 5 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.