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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: Completed Phase 2 study of Pancreatic Cancer, sponsored by INSYS Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measurable disease response will be assessed by radiographic method, CT or MRI, along with serum CA 19-9 after completed 2, 4 and 6 cycle.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT01186731 record still lists
NCT01186731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01186731's enrollment target sits among peer trials
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