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NCT01672736 · ClinicalTrials.gov registry record · Phase 1
A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma
A Phase 1 study, sponsored by University Health Network, Toronto.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01672736: Clinical Trial Phase 1 study, sponsored by University Health Network, Toronto.
NCT01672736 is a Phase 1 study that was terminated before completion, run by University Health Network, Toronto. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01672736, a Phase 1 study, was terminated before completion, sponsored by University Health Network, Toronto.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, non-randomized study. Patients will receive ASP7487 (OSI-906) in combination with bortezomib and dexamethasone. Phase 1 involves dose escalation of the combination, whereas Phase 2 involves the expansion of ASP7487 (OSI-906) combined with bortezomib and dexamethasone at the MTD to establish the ORR. This trial will accrue patients with relapsed or relapsed/refractory MM - a disease state for which bortezomib is approved to treat by the FDA and Health Canada. The combination of ASP7487 (OSI-906) with bortezomib is supported by pre-clinical work in MM in which the combination with an IGF1-R inhibitor enhances anti-tumor activity of bortezomib.
Primary Outcome
* Phase 1: To determine the maximum tolerated dose (MTD) of ASP7487 (OSI-906) administered in combination with the recommended dose and schedule of bortezomib and dexamethasone; * Phase 2: To evaluate the antitumor activity of ASP7487 (OSI-906) in combination with bortezomib and dexamethasone at the MTD established from the Phase 1 component.
Interventions
- DRUG ASP7487, Velcade, Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-12-27 |
| Phase | Phase 1 |
Why NCT01672736 stopped before completion
NCT01672736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which ASP7487, Velcade, Dexamethasone is the first listed.
NCT01672736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01672736 about?
NCT01672736 is a clinical study titled "A Trial of ASP7487 (OSI-906) in Combination With Bortezomib for the Treatment of Relapsed Multiple Myeloma". This is a multi-center, open-label, non-randomized study. Patients will receive ASP7487 (OSI-906) in combination with bortezomib and dexamethasone. Phase 1 involves dose escalation of the combination, whereas Phase 2 involves the expansion of ASP7487 (OSI-906) combined with bortezomib and dexamethas...
What is the current status of trial NCT01672736?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-09. Estimated completion is 2017-12-27.
What interventions are being tested in trial NCT01672736?
The interventions under investigation include: ASP7487, Velcade, Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT01672736?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01672736's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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