Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00111007 · ClinicalTrials.gov registry record · Phase 3
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT00111007: Completed Phase 3 study, sponsored by Bayer.
NCT00111007 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00111007, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine (DTIC) or Temozolomide (TMZ).
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 Sorafenib (Nexavar, BAY43-9006)
- DRUG Carboplatin/Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2005-05 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
What the finished NCT00111007 record still lists
NCT00111007 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00111007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00111007 about?
NCT00111007 is a clinical study titled "A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma". The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival (PFS) and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Sta...
What is the current status of trial NCT00111007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2005-05. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00111007?
The interventions under investigation include: Placebo (DRUG), Sorafenib (Nexavar, BAY43-9006) (DRUG), Carboplatin/Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00111007?
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 NCT00111007's enrollment target sits among peer trials
270 1217th of 2000 higher than 781 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00801489 · 270 participants · Phase 2
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
- NCT04372485 · 270 participants · NA
Using Mobile Health (mHealth) to Improve STI Treatment Adherence Among Adolescents
- NCT04528446 · 270 participants
The Impact of Glomerular Disorders on Bone Quality and Strength
- NCT05215327 · 270 participants · Phase 2
High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia