Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
Public ClinicalTrials.gov record NCT00316511. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Multi-Center, Dose Escalation and Pharmacokinetic Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00316511
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2006
- Primary completion
- May 31, 2008
- Completion
- Not listed
- Last update posted
- Oct 26, 2008
Started 2006
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Houston | Texas | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00316511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2008 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00316511 live on ClinicalTrials.gov.