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NCT01450384 · ClinicalTrials.gov registry record · Phase 1

Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors

A Phase 1 study of Unspecified Adult Solid Tumor, sponsored by Virginia Commonwealth University.

Completed
Registry status
Phase 1
Development phase
37
Enrollment target
1
Study location

NCT01450384: Completed Phase 1 study of Unspecified Adult Solid Tumor, sponsored by Virginia Commonwealth University.

NCT01450384 is a Phase 1 study of Unspecified Adult Solid Tumor that has completed, run by Virginia Commonwealth University. The registered enrollment target is 37 participants, above the 33-participant average among 3 other Unspecified Adult Solid Tumor trials with a reported enrollment target (12% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01450384, a Phase 1 study of Unspecified Adult Solid Tumor, has completed, sponsored by Virginia Commonwealth University.

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

Study Summary

This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate 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 solid tumors by blocking blood flow to the tumor. Giving pemetrexed disodium together with sorafenib tosylate may kill more tumor cells.

Primary Outcome

Maximum doses of pemetrexed and sorafenib, which, when administered in combination are determined to be tolerable and will be tested in a Phase 2 trial for efficacy.

Conditions Studied

Unspecified Adult Solid Tumor

Interventions

  • OTHER laboratory biomarker analysis
  • PROCEDURE biopsy
  • DRUG pemetrexed disodium
  • DRUG sorafenib tosylate

Study Locations (1)

Virginia

  • Virginia Commonwealth University/Massey Cancer Center - Richmond

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2011-10
Est. Completion 2015-09
Phase Phase 1
Virginia Commonwealth University

558 total trials

What the finished NCT01450384 record still lists

NCT01450384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, above the 33-participant average among 3 other Unspecified Adult Solid Tumor trials with a reported enrollment target (12% higher).

The record links to 1 condition, with Unspecified Adult Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT01450384 reports a single indexed study location in Virginia.

Frequently Asked Questions

What is clinical trial NCT01450384 about?

NCT01450384 is a clinical study titled "Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors". This phase I trial studies the side effects and best dose of giving pemetrexed disodium and sorafenib tosylate together in treating patients with advanced solid tumors. Pemetrexed disodium and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growt...

What is the current status of trial NCT01450384?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2011-10. Estimated completion is 2015-09.

What conditions does trial NCT01450384 study?

This clinical trial studies the following conditions: Unspecified Adult Solid Tumor.

What interventions are being tested in trial NCT01450384?

The interventions under investigation include: laboratory biomarker analysis (OTHER), biopsy (PROCEDURE), pemetrexed disodium (DRUG), sorafenib tosylate (DRUG).

Who is sponsoring clinical trial NCT01450384?

This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01450384 being conducted?

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

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Related registry views

Source: ClinicalTrials.gov NCT01450384, the US trial registry maintained by the National Library of Medicine. NCT01450384 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.