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NCT01458392 · ClinicalTrials.gov registry record · Phase 2
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01458392: Completed Phase 2 study, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
NCT01458392 is a Phase 2 study that has completed, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458392, a Phase 2 study, has completed, sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks the development of blood vessels that supply tumors.
Primary Outcome
ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as th
Interventions
- BIOLOGICAL Dalantercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA14 total trials
What the finished NCT01458392 record still lists
NCT01458392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which Dalantercept is the first listed.
NCT01458392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458392 about?
NCT01458392 is a clinical study titled "Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck". Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks the development of blood vessels that supply tumors.
What is the current status of trial NCT01458392?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2011-10. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01458392?
The interventions under investigation include: Dalantercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT01458392?
This trial is sponsored by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01458392's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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