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NCT00113360 · ClinicalTrials.gov registry record · Phase 2
RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
A Phase 2 study of Neuroendocrine Carcinoma and Islet Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT00113360 is a Phase 2 study of Neuroendocrine Carcinoma and Islet Cell Carcinoma that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 67 participants, below the 276-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00113360, a Phase 2 study of Neuroendocrine Carcinoma and Islet Cell Carcinoma, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
Objectives: Primary endpoint: -Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma. Secondary endpoints: * Assess the progression free survival duration of patients with metastatic, unresectable low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide. * Assess the safety of RAD 001 plus depot octreotide in patients with metastatic, unresectable low grade neuroendocrine carcinoma. * To determine the expression/phosphorylation status of the components of the mTOR signaling pathway in the primary tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and octreotide. * To determine the effect of the combination of RAD001 and octreotide on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination. * To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.
Conditions Studied
Interventions
- DRUG RAD001
- DRUG Octreotide Depot
Study Locations (1)
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2005-01 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00113360
The ClinicalTrials.gov registry entry for NCT00113360 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 276-participant average among 13 other Neuroendocrine Carcinoma trials with a reported enrollment target (76% lower). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which RAD001 is the first listed.
NCT00113360 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00113360 about?
NCT00113360 is a clinical study titled "RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma". Objectives: Primary endpoint: -Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma. Secondary endpoints: ...
What is the current status of trial NCT00113360?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2005-01. Estimated completion is 2009-07.
What conditions does trial NCT00113360 study?
This clinical trial studies the following conditions: Neuroendocrine Carcinoma, Islet Cell Carcinoma.
What interventions are being tested in trial NCT00113360?
The interventions under investigation include: RAD001 (DRUG), Octreotide Depot (DRUG).
Who is sponsoring clinical trial NCT00113360?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00113360 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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