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NCT00900562 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy
A Phase 2 study, sponsored by PharmaMar.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT00900562: Clinical Trial Phase 2 study, sponsored by PharmaMar.
NCT00900562 is a Phase 2 study that was terminated before completion, run by PharmaMar. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00900562, a Phase 2 study, was terminated before completion, sponsored by PharmaMar.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in patients with advanced and/or metastatic endometrial or cervical cancer previously treated with one line of systemic chemotherapy to evaluate the antitumor activity and to determine the safety profile, the pharmacokinetic profile and the pharmacogenomic profile.
Primary Outcome
Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.0. CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation C
Interventions
- DRUG Zalypsis ( PM00104)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 2 |
Why NCT00900562 stopped before completion
NCT00900562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Zalypsis ( PM00104) is the first listed.
NCT00900562 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00900562 about?
NCT00900562 is a clinical study titled "Clinical Trial of PM00104 (Zalypsis®) in Patients With Advanced and/or Metastatic Endometrial or Cervical Cancer Previously Treated With One Line of Systemic Chemotherapy". This study is a phase II clinical and pharmacokinetic trial of PM00104 (Zalypsis®) in patients with advanced and/or metastatic endometrial or cervical cancer previously treated with one line of systemic chemotherapy to evaluate the antitumor activity and to determine the safety profile, the pharmaco...
What is the current status of trial NCT00900562?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2009-08. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00900562?
The interventions under investigation include: Zalypsis ( PM00104) (DRUG).
Who is sponsoring clinical trial NCT00900562?
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 NCT00900562's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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