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NCT00131911 · ClinicalTrials.gov registry record · Phase 2

Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

A Phase 2 study of Neuroendocrine Tumor and Insulinoma, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
93
Enrollment target
1
Study location

NCT00131911: Completed Phase 2 study of Neuroendocrine Tumor and Insulinoma, sponsored by National Cancer Institute (NCI).

NCT00131911 is a Phase 2 study of Neuroendocrine Tumor and Insulinoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 93 participants, below the 129-participant average among 6 other Neuroendocrine Tumor trials with a reported enrollment target (28% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00131911, a Phase 2 study of Neuroendocrine Tumor and Insulinoma, has completed, sponsored by National Cancer Institute (NCI).

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

Study Summary

This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Primary Outcome

Confirmed response rate was defined using Response Evaluation Criteria In Solid Tumors (RECIST). A confirmed response is defined as a complete response (CR) or partial response (PR) observed on subsequent scans at least 4 weeks apart. Confirmed response rate was estimated by the number of successes divided by the total number of evaluable patients.\> \> Complete Response (CR) is defined as the disappearance of all target lesions.\> Partial Response (PR) is defined as a 30% decrease in sum of lon

Interventions

  • DRUG sorafenib tosylate

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2005-06
Est. Completion 2013-04
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00131911 record still lists

NCT00131911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 129-participant average among 6 other Neuroendocrine Tumor trials with a reported enrollment target (28% lower).

The record links to 10 conditions, with Neuroendocrine Tumor appearing as the primary indexed condition, and to 1 intervention - of which sorafenib tosylate is the first listed.

NCT00131911 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT00131911 about?

NCT00131911 is a clinical study titled "Sorafenib Tosylate in Treating Patients With Progressive Metastatic Neuroendocrine Tumors". This phase II trial is studying how well sorafenib tosylate works in treating patients with progressive metastatic neuroendocrine tumors. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

What is the current status of trial NCT00131911?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2005-06. Estimated completion is 2013-04.

What conditions does trial NCT00131911 study?

This clinical trial studies the following conditions: Neuroendocrine Tumor, Insulinoma, Metastatic Gastrointestinal Carcinoid Tumor, Gastrinoma, Glucagonoma.

What interventions are being tested in trial NCT00131911?

The interventions under investigation include: sorafenib tosylate (DRUG).

Who is sponsoring clinical trial NCT00131911?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00131911 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT00131911, the US trial registry maintained by the National Library of Medicine. NCT00131911 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.