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NCT00923520 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612) in Advanced Malignancies
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00923520: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923520 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923520, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Background: * Dimethane sulfonate (DMS612) is an investigational drug that is being administered to humans for the first time in people with advanced tumors. More information on the maximum tolerated dose of DMS612 will help researchers identify whether the drug is suitable for use in treating certain kinds of cancer, particularly renal cell carcinoma. Objectives: * To determine the maximum tolerated dose of DMS612 (the highest dose that does not cause unacceptable side effects) and evaluate any side effects. * To see if DMS612 has any effect on patients tumors through blood tests and laboratory studies. * To learn how the body processes DMS612. Eligibility: * Patients 18 years of age and older who have been diagnosed with cancer that has not responded well to standard treatments. Design: * Pre-treatment evaluation visit to determine eligibility: * Physical examination * Blood and urine tests * Chest X-ray; electrocardiogram; CAT scan of chest, abdomen, pelvis, and other areas of the body if needed * Other possible tests, such as magnetic resonance imaging (MRI) or positron emission tomography (PET) * Patients will receive one dose of DMS612 by intravenous infusion once a week for 3 weeks, followed by 1 week without the drug. Doses will be adjusted based on possible side effects and cancer response. The disease will be evaluated after three cycles of the drug. * Evaluations during the treatment period: * Physical examination and reviews of side effects. * Blood draws to evaluate the effectiveness of the drug, and how it is processed by the body. * CAT scan at the end of every two cycles (every 8 weeks). * Other scans and imaging procedures as required by the study doctors.
Primary Outcome
Number of DLTs in on a given dose level.
Interventions
- DRUG DMS 612
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-03-25 |
| Est. Completion | 2018-12-03 |
| Phase | Phase 1 |
What the finished NCT00923520 record still lists
NCT00923520 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which DMS 612 is the first listed.
NCT00923520 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00923520 about?
NCT00923520 is a clinical study titled "A Phase 1, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Dimethane Sulfonate (DMS612) in Advanced Malignancies". Background: * Dimethane sulfonate (DMS612) is an investigational drug that is being administered to humans for the first time in people with advanced tumors. More information on the maximum tolerated dose of DMS612 will help researchers identify whether the drug is suitable for use in treating cert...
What is the current status of trial NCT00923520?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2009-03-25. Estimated completion is 2018-12-03.
What interventions are being tested in trial NCT00923520?
The interventions under investigation include: DMS 612 (DRUG).
Who is sponsoring clinical trial NCT00923520?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00923520's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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