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NCT00110994 · ClinicalTrials.gov registry record · Phase 2
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT00110994: Completed Phase 2 study, sponsored by Bayer.
NCT00110994 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00110994, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.
Primary Outcome
PFS was calculated as the time (days) from date of randomization to date of first observed DP (per modified Response Evaluation Criteria In Solid Tumors \[RECIST\] or clinical judgment, whichever was earlier: CR, PR, stable disease, progressive disease) or death due to any cause, if death occurred before progression was documented. The actual date of tumor assessments was used for this calculation. PFS for subjects without progression or death was censored at the last date of tumor evaluation. P
Interventions
- DRUG Placebo
- DRUG Dacarbazine
- DRUG Sorafenib (Nexavar, BAY43-9006)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2005-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00110994 record still lists
NCT00110994 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00110994 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00110994 about?
NCT00110994 is a clinical study titled "Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma". This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unre...
What is the current status of trial NCT00110994?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2005-04. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00110994?
The interventions under investigation include: Placebo (DRUG), Dacarbazine (DRUG), Sorafenib (Nexavar, BAY43-9006) (DRUG).
Who is sponsoring clinical trial NCT00110994?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00110994's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 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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