Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00861783 · ClinicalTrials.gov registry record · Phase 1
Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma
A Phase 1 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00861783 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 16 participants.
The verdict
NCT00861783, a Phase 1 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Studies done in the laboratory have demonstrated beneficial effects of ON 01910.Na, a new, unapproved drug, when it is used in combination either irinotecan and oxaliplatin, two approved, extensively used anti-cancer drugs. In these laboratory studies, mice implanted with cells (Bel-7402 cells) that came from a human tumor were used as a model of liver cancer. In mice that were not treated, the Bel-7402 cells formed very large tumors. In mice that were treated with ON 01910.Na, irinotecan or oxaliplatin alone, growth of tumors was reduced compared to the untreated group. When a combination of ON 01910.Na and irinotecan or of ON 01910.Na and oxaliplatin was used to treat the mice, tumor growth was completely inhibited. Another observation in these studies was that toxicity did not increase when the combinations were used. These results and similar results from other studies support the hypothesis that a combination of ON 01910.Na and irinotecan or of ON 01910.Na and oxaliplatin would be an effective and tolerable treatment for liver and other types of cancer. The primary objective of this phase 1 study is to find out what doses of ON 01910.Na in combination with either irinotecan or oxaliplatin are safe and tolerable in patients with liver and other types of cancer.
Interventions
- DRUG irinotecan and ON 01910.Na
- DRUG oxaliplatin and ON 01910.Na
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2008-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00861783
The ClinicalTrials.gov registry entry for NCT00861783 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Traws Pharma, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which irinotecan and ON 01910.Na is the first listed.
NCT00861783 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00861783 about?
NCT00861783 is a clinical study titled "Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma". Studies done in the laboratory have demonstrated beneficial effects of ON 01910.Na, a new, unapproved drug, when it is used in combination either irinotecan and oxaliplatin, two approved, extensively used anti-cancer drugs. In these laboratory studies, mice implanted with cells (Bel-7402 cells) that...
What is the current status of trial NCT00861783?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2008-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00861783?
The interventions under investigation include: irinotecan and ON 01910.Na (DRUG), oxaliplatin and ON 01910.Na (DRUG).
Who is sponsoring clinical trial NCT00861783?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.