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NCT00267046 · ClinicalTrials.gov registry record · Phase 2
Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT00267046: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00267046 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00267046, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy. 2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy. 3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy. Exploratory: 1. To evaluate the biologic effect of palifermin on oral mucosa. 2. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma. 3. To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen.
Primary Outcome
Cumulative incidence of World Health Organization (WHO) grade 2 or \> mucositis (moderate to severe) in participants completing up to 6 blinded cycles. Rate defined as participants who had Grade 2 or \> divided by total number of participants who completed up to 6 blinded cycles. WHO Criteria of Grade 1: possible buccal mucosal scalloping with/without erythema; No ulcers; swallows solid diet. Grade 2: ulcers with or without erythema; swallow solid diet. Grade 3: ulcers with/without (extensive)
Interventions
- DRUG Placebo
- DRUG Vincristine
- DRUG Ifosfamide
- DRUG Palifermin
- DRUG Adriamycin (Doxorubicin)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2005-12 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
What the finished NCT00267046 record still lists
NCT00267046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00267046 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00267046 about?
NCT00267046 is a clinical study titled "Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma". Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy. 2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy. 3. To evaluate the safety prof...
What is the current status of trial NCT00267046?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2005-12. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00267046?
The interventions under investigation include: Placebo (DRUG), Vincristine (DRUG), Ifosfamide (DRUG), Palifermin (DRUG), Adriamycin (Doxorubicin) (DRUG).
Who is sponsoring clinical trial NCT00267046?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00267046's enrollment target sits among peer trials
49 1261st of 2000 higher than 736 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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