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Dose Escalation Study of Gemcitabine and ON 01910.Na in Solid Tumors
NCT01125891 · 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. This study is designed to answer that question.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01125891
The ClinicalTrials.gov registry entry for NCT01125891 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 39 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 2 conditions, with Solid Tumors 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: NCT01125891 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Colorado, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01125891?
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 NCT01125891?
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 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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