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NCT01186731 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer

A Phase 2 study of Pancreatic Cancer, sponsored by INSYS Therapeutics.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT01186731 is a Phase 2 study of Pancreatic Cancer that has completed, run by INSYS Therapeutics. The registered enrollment target is 40 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01186731, a Phase 2 study of Pancreatic Cancer, has completed, sponsored by INSYS Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeutic efficacy in pre-clinical study. The clinical evidence obtained from the NeoPharm Phase I study shows fewer side effects and possibly administered at higher dose to induce greater effectiveness of LE-DT. In addition, docetaxel has shown positive activity of protein bound taxane therapy in treating patients with pancreatic cancer. The current Phase II study is designed to accomplish the following objectives: 1. Assess the antitumor effect of 110 mg/m2 LE-DT administered intravenous (IV) every three weeks in pancreatic cancer patients with locally advanced or metastatic disease 2. To evaluate the progression-free survival and overall survival 3. To correlate secreted protein acid rich in cysteine expression with tumor response 4. To evaluate the safety of LE-DT, in particular peripheral neuropathy, water retention as well as myelotoxicity 5. To correlate pharmacogenetic variations in patients with LE-DT pharmacodynamic endpoints, including toxicities.

Conditions Studied

Pancreatic Cancer

Interventions

  • DRUG Liposome Entrapped Docetaxel (LE-DT)

Study Locations (1)

District of Columbia

  • Lombardi Cancer Center, Georgetown University Medical Center - Washington D.C.

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2010-04
Est. Completion 2011-12
Phase Phase 2

Sponsor

INSYS Therapeutics

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01186731

The ClinicalTrials.gov registry entry for NCT01186731 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 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 (90% lower). The listed sponsor is INSYS Therapeutics, which has 35 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 Liposome Entrapped Docetaxel (LE-DT) is the first listed.

NCT01186731 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT01186731 about?

NCT01186731 is a clinical study titled "Efficacy and Safety Study of LE-DT to Treat Locally Advanced or Metastatic Pancreatic Cancer". LE-DT is a novel, proprietary delivery system of docetaxel developed by NeoPharm, Inc. Docetaxel (currently marketed as Taxotere) is an anti-microtubule agent that prevents cell division. By removing toxic detergent used in Taxotere, the form of LE-DT, shows reduced toxicity and comparable therapeut...

What is the current status of trial NCT01186731?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2010-04. Estimated completion is 2011-12.

What conditions does trial NCT01186731 study?

This clinical trial studies the following conditions: Pancreatic Cancer.

What interventions are being tested in trial NCT01186731?

The interventions under investigation include: Liposome Entrapped Docetaxel (LE-DT) (DRUG).

Who is sponsoring clinical trial NCT01186731?

This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01186731 being conducted?

This trial has 1 study location across District of Columbia. 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.