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NCT01125891 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation Study of Gemcitabine and ON 01910.Na in Solid Tumors

A Phase 1 study of Solid Tumors and Malignant Neoplasmas, sponsored by Traws Pharma.

Completed
Registry status
Phase 1
Development phase
39
Enrollment target
2
Study locations

NCT01125891 is a Phase 1 study of Solid Tumors and Malignant Neoplasmas that has completed, run by Traws Pharma. The registered enrollment target is 39 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (86% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01125891, a Phase 1 study of Solid Tumors and Malignant Neoplasmas, has completed, sponsored by Traws Pharma.

COMPLETED
Registry status
Phase 1
Development phase
39 participants
Enrollment target
2
Study locations

Study Summary

Treatment of cancer is often more effective when two or more drugs are used together. For example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is more inhibition of the growth of the cancer cells compared to either drug used by itself. These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an effective combination in patients can be done, doctors must first know what is largest, safe dose of ON 01910.Na that can be used in combination with gemcitabine. This study is designed to answer that question.

Interventions

  • DRUG gemcitabine
  • DRUG ON 01910.Na

Study Locations (2)

Colorado

  • University of Colorado Cancer Center - Denver

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2009-01
Est. Completion 2011-09
Phase Phase 1

Sponsor

Traws Pharma

25 total trials

What the Registry Record Tells You About NCT01125891

The ClinicalTrials.gov registry entry for NCT01125891 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (86% lower). The listed sponsor is Traws Pharma, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which gemcitabine is the first listed.

NCT01125891 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, New York.

Frequently Asked Questions

What is clinical trial NCT01125891 about?

NCT01125891 is a clinical study titled "Dose Escalation Study of Gemcitabine and ON 01910.Na in Solid Tumors". Treatment of cancer is often more effective when two or more drugs are used together. For example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is more inhibition of the growth of the...

What is the current status of trial NCT01125891?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2009-01. Estimated completion is 2011-09.

What conditions does trial NCT01125891 study?

This clinical trial studies the following conditions: Solid Tumors, Malignant Neoplasmas.

What interventions are being tested in trial NCT01125891?

The interventions under investigation include: gemcitabine (DRUG), ON 01910.Na (DRUG).

Who is sponsoring clinical trial NCT01125891?

This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01125891 being conducted?

This trial has 2 study locations across Colorado, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.