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COMPLETED Phase 1

Safety of 24-hour Infusion of ON 01910.Na in Combination With Gemcitabine in Advanced Solid Tumors

NCT01165905 · View on ClinicalTrials.gov ↗

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 and what is the best regimen to use. This study is designed to answer that question.

Conditions Studied

Interventions

  • DRUG Gemcitabine
  • DRUG ON 01910.Na

Study Locations (2)

California

  • Department of Medicine, University of California San Francisco — San Francisco

New York

  • Albert Einstein Cancer Center/Montefiore Medical Center — The Bronx

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2010-01
Est. Completion 2011-07
Phase Phase 1

Sponsor

Traws Pharma

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01165905

The ClinicalTrials.gov registry entry for NCT01165905 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Traws Pharma, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Gemcitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01165905 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01165905 about?

NCT01165905 is a clinical study titled "Safety of 24-hour Infusion of ON 01910.Na in Combination With Gemcitabine in Advanced 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 NCT01165905?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2010-01. Estimated completion is 2011-07.

What conditions does trial NCT01165905 study?

This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01165905?

The interventions under investigation include: Gemcitabine (DRUG), ON 01910.Na (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01165905?

This trial is sponsored by Traws Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01165905 being conducted?

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

Related

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