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NCT01445392 · ClinicalTrials.gov registry record · Phase 1
SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01445392: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01445392 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445392, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen. SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin (type of poison) made from a product of a bacterium called Pseudomonas aeruginosa. It is hoped that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells. Objectives: To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma. To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects). To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients tumors. To learn how the body breaks down SS1(dsFV)PE38. Eligibility: Patients 18 years of age and older with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy. Design: Treatment with pemetrexed, cisplatin and SS1(dsFV)PE38 in two 21-day cycles as follows: * Day 1 - Intravenous (through a vein) infusions of pemetrexed and cisplatin. * Days 1 and 2 - Intravenous solution to prevent dehydration that might occur with SS1(dsFV)PE38. * Days 1, 3 and 5 Intravenous infusion of SS1(dsFV)PE38. Small groups (3 to 6) of patients are given SS1(dsFV)PE38 at a certain dose level. If the first group experiences no significant side effects, the next group a higher dose. This continues in succeeding groups until the maximum tolerated study dose (highest dose that patients can be given safely) is determined. Continuing standard treatment with additional cycles of pemetrexed and cisplatin. Evaluations during the treatment period: * Physical examination, including vital signs and body weight checks, and pregnancy test f
Primary Outcome
list of adverse events and highest dose at which fewer than 2 subjects experienced DLT
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- BIOLOGICAL Multicycle SS1P
- BIOLOGICAL Single cycle SS1P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-11-14 |
| Est. Completion | 2016-10-03 |
| Phase | Phase 1 |
Why NCT01445392 stopped before completion
NCT01445392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT01445392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01445392 about?
NCT01445392 is a clinical study titled "SS1(dsFV)PE38 Plus Pemetrexed and Cisplatin to Treat Malignant Pleural Mesothelioma". Background: Standard therapy for mesothelioma is a combination of the drugs pemetrexed and cisplatin. However, the benefits of this treatment are limited, and in most treated patients the disease continues to worsen. SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that bind...
What is the current status of trial NCT01445392?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2007-11-14. Estimated completion is 2016-10-03.
What interventions are being tested in trial NCT01445392?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Multicycle SS1P (BIOLOGICAL), Single cycle SS1P (BIOLOGICAL).
Who is sponsoring clinical trial NCT01445392?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01445392's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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