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NCT00856791 · ClinicalTrials.gov registry record · Phase 2

Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients

A Phase 2 study, sponsored by Traws Pharma.

Completed
Registry status
Phase 2
Development phase
1
Enrollment target

NCT00856791: Completed Phase 2 study, sponsored by Traws Pharma.

NCT00856791 is a Phase 2 study that has completed, run by Traws Pharma. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00856791, a Phase 2 study, has completed, sponsored by Traws Pharma.

COMPLETED
Registry status
Phase 2
Development phase
1 participants
Enrollment target

Study Summary

ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progression free survival rates in patients with platinum-resistant ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.

Primary Outcome

Progression-free survival, defined as the number of days from the first day of study drug dosing to the day of documented disease progression or death, as assessed using RECIST (Response Evaluation Criteria in Solid Tumors) guidelines according to Therasse P, Arbuck SF, Eisenhauer EA, et al. (2000) J Natl Cancer Inst. 92:205-216. Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD)of target lesions, taking as reference the smallest sum LD recorded sin

Interventions

  • DRUG ON 01910.Na

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2009-03
Est. Completion 2011-07
Phase Phase 2
Traws Pharma

25 total trials

What the finished NCT00856791 record still lists

NCT00856791 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which ON 01910.Na is the first listed.

NCT00856791 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00856791 about?

NCT00856791 is a clinical study titled "Effect of 2-h Infusion of ON 01910.Na in Ovarian Cancer Patients". ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progres...

What is the current status of trial NCT00856791?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-03. Estimated completion is 2011-07.

What interventions are being tested in trial NCT00856791?

The interventions under investigation include: ON 01910.Na (DRUG).

Who is sponsoring clinical trial NCT00856791?

This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00856791's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00856791, the US trial registry maintained by the National Library of Medicine. NCT00856791 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.