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NCT01063907 · ClinicalTrials.gov registry record · Phase 1
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study, sponsored by Kyowa Kirin Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT01063907 is a Phase 1 study that has completed, run by Kyowa Kirin Co.. The registered enrollment target is 95 participants.
The verdict
NCT01063907, a Phase 1 study, has completed, sponsored by Kyowa Kirin Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); * To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: * To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); * To evaluate for preliminary evidence of efficacy (Phase I); * To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).
Interventions
- DRUG Bortezomib
- DRUG KW-2478
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01063907
The ClinicalTrials.gov registry entry for NCT01063907 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin Co., which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bortezomib is the first listed.
NCT01063907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01063907 about?
NCT01063907 is a clinical study titled "A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma". The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II do...
What is the current status of trial NCT01063907?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2010-03. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01063907?
The interventions under investigation include: Bortezomib (DRUG), KW-2478 (DRUG).
Who is sponsoring clinical trial NCT01063907?
This trial is sponsored by Kyowa Kirin Co., which has 25 total clinical trials registered on ClinicalTrials.gov.
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