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Safety Study of ON 01910.Na in Combination With Irinotecan or Oxaliplatin
NCT00861328 · View on ClinicalTrials.gov ↗
Study Summary
Treatment of cancer is often improved if two or more drugs are used in combination. In animal studies, the use of the combination of ON 01910.Na (a new, unapproved drug) and irinotecan or oxaliplatin (two approved and extensively used anti-cancer drugs) gave better results against tumor cells than the use of any of the single drugs alone. In addition, the use of the combinations did not result in an increase of side effects. This clinical trial will determine what is the highest dose of ON 01910.Na that can be given safely in combination with either irinotecan or oxaliplatin in human patients.
Conditions Studied
Interventions
- DRUG ON 01910.Na and irinotecan
- DRUG ON 01910.Na and oxaliplatin
Study Locations (1)
New York
- Albert Einstein Cancer Center — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-02 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00861328
The ClinicalTrials.gov registry entry for NCT00861328 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 18 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 Advanced Solid Tumors appearing as the primary indexed condition, and to 2 interventions — of which ON 01910.Na and irinotecan 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: NCT00861328 reports 1 study location spanning 1 distinct geographic area — top geographies include 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 NCT00861328 about?
NCT00861328 is a clinical study titled "Safety Study of ON 01910.Na in Combination With Irinotecan or Oxaliplatin". Treatment of cancer is often improved if two or more drugs are used in combination. In animal studies, the use of the combination of ON 01910.Na (a new, unapproved drug) and irinotecan or oxaliplatin (two approved and extensively used anti-cancer drugs) gave better results against tumor cells than t...
What is the current status of trial NCT00861328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-02. Estimated completion is 2011-07.
What conditions does trial NCT00861328 study?
This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00861328?
The interventions under investigation include: ON 01910.Na and irinotecan (DRUG), ON 01910.Na and oxaliplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00861328?
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 NCT00861328 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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