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NCT01309789 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT01309789 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 39 participants.
The verdict
NCT01309789, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
Interventions
- DRUG prednisone
- DRUG cyclophosphamide
- DRUG brentuximab vedotin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2011-02 |
| Est. Completion | 2017-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01309789
The ClinicalTrials.gov registry entry for NCT01309789 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 84 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which prednisone is the first listed.
NCT01309789 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01309789 about?
NCT01309789 is a clinical study titled "A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms". The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label...
What is the current status of trial NCT01309789?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2011-02. Estimated completion is 2017-02-28.
What interventions are being tested in trial NCT01309789?
The interventions under investigation include: prednisone (DRUG), cyclophosphamide (DRUG), brentuximab vedotin (DRUG).
Who is sponsoring clinical trial NCT01309789?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
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