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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: Completed Phase 1 study of Solid Tumors and Malignant Neoplasmas, sponsored by Traws Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of adverse events, including laboratory parameters, as assessed by NCI CTCAE v3.0.
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 |
What the finished NCT01125891 record still lists
NCT01125891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01125891's enrollment target sits among peer trials
39 101st of 125 higher than 25 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
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A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
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-
Study of AUBE00 in Patients With Solid Tumors
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