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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: Completed Phase 1 study, sponsored by Kyowa Kirin Co..
NCT01063907 is a Phase 1 study that has completed, run by Kyowa Kirin Co.. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or deat
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 |
What the finished NCT01063907 record still lists
NCT01063907 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Bortezomib is the first listed.
NCT01063907 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01063907's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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