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NCT01248923 · ClinicalTrials.gov registry record · Phase 1
A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
NCT01248923 is a Phase 1 study that has completed, run by Array Biopharma, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 55 participants.
The verdict
NCT01248923, a Phase 1 study, has completed, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
Study Summary
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).
Interventions
- DRUG ARRY-520, KSP(Eg5) inhibitor; intravenous
- DRUG Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- DRUG Dexamethasone, steroid; oral
- DRUG Bortezomib, proteasome inhibitor; intravenous or subcutaneous
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248923
The ClinicalTrials.gov registry entry for NCT01248923 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 Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which ARRY-520, KSP(Eg5) inhibitor; intravenous is the first listed.
NCT01248923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248923 about?
NCT01248923 is a clinical study titled "A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma". This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 ...
What is the current status of trial NCT01248923?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2010-12.
What interventions are being tested in trial NCT01248923?
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), Bortezomib, proteasome inhibitor; intravenous or subcutaneous (DRUG).
Who is sponsoring clinical trial NCT01248923?
This trial is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total clinical trials registered on ClinicalTrials.gov.
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