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NCT01222767 · ClinicalTrials.gov registry record · Phase 2
Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy
A Phase 2 study, sponsored by PharmaMar.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01222767: Completed Phase 2 study, sponsored by PharmaMar.
NCT01222767 is a Phase 2 study that has completed, run by PharmaMar. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222767, a Phase 2 study, has completed, sponsored by PharmaMar.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the antitumor activity of Zalypsis.
Primary Outcome
Overall response rate (ORR), defined as the percentage of patients with confirmed objective response (OR), either CR or PR according to the RECIST v.1.1. 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 Evalu
Interventions
- DRUG Zalypsis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01222767 record still lists
NCT01222767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Zalypsis is the first listed.
NCT01222767 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01222767 about?
NCT01222767 is a clinical study titled "Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy". This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy to determine the antitumor activity of Zalypsi...
What is the current status of trial NCT01222767?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-12. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01222767?
The interventions under investigation include: Zalypsis (DRUG).
Who is sponsoring clinical trial NCT01222767?
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 NCT01222767's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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