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NCT00316511 · ClinicalTrials.gov registry record · Phase 1
Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
A Phase 1 study, sponsored by Agenus.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT00316511 is a Phase 1 study that has completed, run by Agenus. The registered enrollment target is 21 participants.
The verdict
NCT00316511, a Phase 1 study, has completed, sponsored by Agenus.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP. Once the MTD has been determined, an additional four patients will be enrolled at that dose level. While the MTD is determined based on safety data from each cohort's first cycle of L-NDDP therapy only, patients may continue treatment with additional cycles of L-NDDP at the same dose as their starting dose until documented progression, unacceptable toxicity, or another off study criterion is met. Patients who have not met any of the off study criteria and continue to receive L-NDDP therapy at the time when MTD is determined may be allowed to change L-NDDP dose to the MTD dose level. The study will also determine the pharmacokinetic profile of L-NDDP administration. Clinical activity of L-NDDP in solid tumor patients will be assessed as tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Clinical activity of L-NDDP in B-cell lymphoma patients will be assessed using the International Working Group recommendations.
Interventions
- DRUG Aroplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2006-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00316511
The ClinicalTrials.gov registry entry for NCT00316511 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Agenus, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aroplatin is the first listed.
NCT00316511 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00316511 about?
NCT00316511 is a clinical study titled "Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma". This is a dose escalation study. Patients will be enrolled in cohorts of three patients each, and escalation of dose to the next cohort will be determined based on dose-limiting toxicity (DLT) in the previous cohort. This study aims to identify the maximum tolerated dose (MTD) of intravenous L-NDDP....
What is the current status of trial NCT00316511?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2006-03.
What interventions are being tested in trial NCT00316511?
The interventions under investigation include: Aroplatin (DRUG).
Who is sponsoring clinical trial NCT00316511?
This trial is sponsored by Agenus, which has 24 total clinical trials registered on ClinicalTrials.gov.
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