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NCT00821249 · ClinicalTrials.gov registry record · Phase 1
A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT00821249 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 55 participants.
The verdict
NCT00821249, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520. The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting). In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (Active, not recruiting).
Interventions
- DRUG ARRY-520, KSP(Eg5) inhibitor; intravenous
- DRUG Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- DRUG Dexamethasone, steroid; oral
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2009-01 |
| Est. Completion | 2016-03-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00821249
The ClinicalTrials.gov registry entry for NCT00821249 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which ARRY-520, KSP(Eg5) inhibitor; intravenous is the first listed.
NCT00821249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00821249 about?
NCT00821249 is a clinical study titled "A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma". This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520. The study has 3 parts. In the first part of the study, Phase 1...
What is the current status of trial NCT00821249?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2009-01. Estimated completion is 2016-03-16.
What interventions are being tested in trial NCT00821249?
The interventions under investigation include: ARRY-520, KSP(Eg5) inhibitor; intravenous (DRUG), Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous (DRUG), Dexamethasone, steroid; oral (DRUG).
Who is sponsoring clinical trial NCT00821249?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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