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NCT00841191 · ClinicalTrials.gov registry record · Phase 1
A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors
A Phase 1 study, sponsored by Centocor.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
NCT00841191: Completed Phase 1 study, sponsored by Centocor.
NCT00841191 is a Phase 1 study that has completed, run by Centocor. The registered enrollment target is 84 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841191, a Phase 1 study, has completed, sponsored by Centocor.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.
Primary Outcome
The CBR is a confirmed complete response (CR), partial response (PR), or stable disease (SD) lasting at least for 6 weeks as per response evaluation criteria in solid tumors (RECIST) criteria. CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least 30 percent decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qual
Interventions
- DRUG CNTO 328; Anti-interleukin-6 monoclonal antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-04 |
| Phase | Phase 1 |
What the finished NCT00841191 record still lists
NCT00841191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% higher).
The record links to 0 conditions, and to 1 intervention - of which CNTO 328; Anti-interleukin-6 monoclonal antibody is the first listed.
NCT00841191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00841191 about?
NCT00841191 is a clinical study titled "A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors". The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcom...
What is the current status of trial NCT00841191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2009-03. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00841191?
The interventions under investigation include: CNTO 328; Anti-interleukin-6 monoclonal antibody (DRUG).
Who is sponsoring clinical trial NCT00841191?
This trial is sponsored by Centocor, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00841191's enrollment target sits among peer trials
84 659th of 2000 higher than 1,336 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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