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NCT01078649 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas
A Phase 1 study, sponsored by Debiopharm International.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT01078649: Completed Phase 1 study, sponsored by Debiopharm International.
NCT01078649 is a Phase 1 study that has completed, run by Debiopharm International. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01078649, a Phase 1 study, has completed, sponsored by Debiopharm International.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety profile and the maximum dose of Debio 1143 (AT-406) that can be given to humans. This study is also designed to measure how much Debio 1143 (AT-406) gets into the blood stream (pharmacokinetics), and how Debio 1143 (AT-406) interacts with proteins related to cancer that the drug is targeted to affect (pharmacodynamics).
Primary Outcome
The primary endpoint of this study is to characterize the safety, and determine the maximum tolerated dose and schedule of Debio 1143 (AT-406) when administered to patients with advanced cancer. Patients will receive Debio 1143 (AT-406) on days 1-5, and 15-19 of a 28 day cycle, days 1-5 of a 21 day cycle, or days 1-14 of a 21 day cycle. For the purpose of determining the MTD, dose limiting toxicities will be evaluated at any time. For the purpose of dose escalation, dose limiting toxicities will
Interventions
- DRUG Debio 1143 (AT-406)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2010-03-29 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01078649 record still lists
NCT01078649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 1 intervention - of which Debio 1143 (AT-406) is the first listed.
NCT01078649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01078649 about?
NCT01078649 is a clinical study titled "Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas". The purpose of this study is to determine the safety profile and the maximum dose of Debio 1143 (AT-406) that can be given to humans. This study is also designed to measure how much Debio 1143 (AT-406) gets into the blood stream (pharmacokinetics), and how Debio 1143 (AT-406) interacts with proteins...
What is the current status of trial NCT01078649?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2010-03-29. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01078649?
The interventions under investigation include: Debio 1143 (AT-406) (DRUG).
Who is sponsoring clinical trial NCT01078649?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01078649's enrollment target sits among peer trials
51 969th of 2000 higher than 1,028 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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