Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00267046
The ClinicalTrials.gov registry entry for NCT00267046 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00267046 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.