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NCT00359294 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma
A Phase 1 study, sponsored by PharmaMar.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00359294: Clinical Trial Phase 1 study, sponsored by PharmaMar.
NCT00359294 is a Phase 1 study that was terminated before completion, run by PharmaMar. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359294, a Phase 1 study, was terminated before completion, sponsored by PharmaMar.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma.
Primary Outcome
DLTs were defined as follows: * Hematological adverse events: * Any grade 4 neutropenia (absolute neutrophil count (ANC) \< 0.5 x109/l) for longer than five days; * Any grade 4 neutropenia accompanied by fever (at least 38.5°C); * Any grade 4 neutropenia and sepsis or other severe infection; * Any grade 4 thrombocytopenia. * Any other grade 3/4 non-hematological adverse event (AE) and any increase of cardiac troponin I ≥0.1 ng/ml together with evidence of cardiac damage by electrocardi
Interventions
- DRUG PM00104
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-09 |
| Phase | Phase 1 |
Why NCT00359294 stopped before completion
NCT00359294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which PM00104 is the first listed.
NCT00359294 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00359294 about?
NCT00359294 is a clinical study titled "A Phase I Study of Zalypsis (PM00104) in Subjects With Advanced Malignant Solid Tumors or Lymphoma". Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is consider...
What is the current status of trial NCT00359294?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-05. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00359294?
The interventions under investigation include: PM00104 (DRUG).
Who is sponsoring clinical trial NCT00359294?
This trial is sponsored by PharmaMar, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00359294's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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