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NCT00051597 · ClinicalTrials.gov registry record · Phase 1
A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT00051597 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 70 participants.
The verdict
NCT00051597, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies. This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.
Interventions
- DRUG SGN-30 (monoclonal antibody)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Est. Completion | 2003-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00051597
The ClinicalTrials.gov registry entry for NCT00051597 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 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 1 intervention - of which SGN-30 (monoclonal antibody) is the first listed.
NCT00051597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00051597 about?
NCT00051597 is a clinical study titled "A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies". The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies. This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (P...
What is the current status of trial NCT00051597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. Estimated completion is 2003-08.
What interventions are being tested in trial NCT00051597?
The interventions under investigation include: SGN-30 (monoclonal antibody) (DRUG).
Who is sponsoring clinical trial NCT00051597?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
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