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NCT00981162 · ClinicalTrials.gov registry record · Phase 1

Sorafenib Tosylate and Everolimus in Treating Patients With Advanced Solid Tumors and Metastatic Pancreatic Cancer That Does Not Respond to Gemcitabine Hydrochloride

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00981162: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT00981162 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00981162, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

This phase I/II trial is studying the side effects and best dose of everolimus when given together with sorafenib tosylate and to see how well they work in treating patients with advanced solid tumors and metastatic pancreatic cancer that does not respond to gemcitabine hydrochloride. Sorafenib tosylate and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving sorafenib tosylate together with everolimus may kill more tumor cells.

Primary Outcome

The estimated distribution of overall survival will be obtained using the product-limit based Kaplan-Meier method. Estimates of quantities such as median survival will be obtained.

Interventions

  • OTHER laboratory biomarker analysis
  • OTHER pharmacological study
  • DRUG everolimus
  • OTHER pharmacogenomic studies
  • DRUG sorafenib tosylate

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2009-08
Est. Completion 2012-12
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

What the finished NCT00981162 record still lists

NCT00981162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 5 interventions - of which laboratory biomarker analysis is the first listed.

NCT00981162 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00981162 about?

NCT00981162 is a clinical study titled "Sorafenib Tosylate and Everolimus in Treating Patients With Advanced Solid Tumors and Metastatic Pancreatic Cancer That Does Not Respond to Gemcitabine Hydrochloride". This phase I/II trial is studying the side effects and best dose of everolimus when given together with sorafenib tosylate and to see how well they work in treating patients with advanced solid tumors and metastatic pancreatic cancer that does not respond to gemcitabine hydrochloride. Sorafenib tosy...

What is the current status of trial NCT00981162?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-08. Estimated completion is 2012-12.

What interventions are being tested in trial NCT00981162?

The interventions under investigation include: laboratory biomarker analysis (OTHER), pharmacological study (OTHER), everolimus (DRUG), pharmacogenomic studies (OTHER), sorafenib tosylate (DRUG).

Who is sponsoring clinical trial NCT00981162?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00981162's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00981162, the US trial registry maintained by the National Library of Medicine. NCT00981162 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.