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NCT01119664 · ClinicalTrials.gov registry record · Phase 1
Combination Gene Transfer and Chemotherapy
A Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01119664: Completed Phase 1 study, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01119664 is a Phase 1 study that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01119664, a Phase 1 study, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to find the safety of combination gene therapy and chemotherapy in patients with malignant pleural mesothelioma. Pleural catheter will be placed first, then pts will receive 2 doses of intrapleural vector followed by front line or second line chemotherapy 4-6 cycles every 21 days.
Primary Outcome
No dose escalation is planned; however, dose de-escalation is possible should two or more DLTs be encountered in the first six patients treated. With 0 DLTs in 6 patients at a given dose, the upper exact 90% confidence limit on the DLT rate is 32%. With 1 DLT in 6 patients, the Bayesian upper 90% probability limit on the DLT rate is 58%. With 10 subjects per treatment group, we can identify with 90% power any unanticipated toxicity that has prevalence at least 20.6%; with n=15 per group, this fi
Interventions
- DRUG SCH 721015
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2010-04-27 |
| Est. Completion | 2017-03-17 |
| Phase | Phase 1 |
What the finished NCT01119664 record still lists
NCT01119664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which SCH 721015 is the first listed.
NCT01119664 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01119664 about?
NCT01119664 is a clinical study titled "Combination Gene Transfer and Chemotherapy". The purpose of this study is to find the safety of combination gene therapy and chemotherapy in patients with malignant pleural mesothelioma. Pleural catheter will be placed first, then pts will receive 2 doses of intrapleural vector followed by front line or second line chemotherapy 4-6 cycles ever...
What is the current status of trial NCT01119664?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2010-04-27. Estimated completion is 2017-03-17.
What interventions are being tested in trial NCT01119664?
The interventions under investigation include: SCH 721015 (DRUG).
Who is sponsoring clinical trial NCT01119664?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01119664's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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