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NCT01020292 · ClinicalTrials.gov registry record · Phase 1
A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma
A Phase 1 study of Glioma, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01020292 is a Phase 1 study of Glioma that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 31 participants, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01020292, a Phase 1 study of Glioma, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a standard therapy for patients with HIV and the safety of 1250 mg BID NFV is well-established. Case studies have also reported that HIV patients have received radiotherapy for cancer, while on 1250 mg BID NFV. This is the first trial of oral NFV and chemoradiotherapy for GBM patients. Although unacceptable toxicity is unlikely, two NFV dose levels (625, and 1250 mg BID) will be evaluated in a cohort escalation design of 3-6 subjects. At the MTD, 19 additional subjects will be enrolled to generate pilot data on radiographic response and to evaluate further toxicity. A maximum of 31 subjects will be enrolled on the trial.
Conditions Studied
Interventions
- DRUG Nelfinavir
Study Locations (1)
Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-04 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01020292
The ClinicalTrials.gov registry entry for NCT01020292 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 210-participant average among 87 other Glioma trials with a reported enrollment target (85% lower). The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioma appearing as the primary indexed condition, and to 1 intervention - of which Nelfinavir is the first listed.
NCT01020292 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01020292 about?
NCT01020292 is a clinical study titled "A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma". This phase I trial will determine safety, dose-limiting toxicities (DLT) and maximum tolerable dose (MTD) of the protease inhibitor, Nelfinavir (NFV), when given with chemoradiotherapy as post-operative therapy for glioblastoma multiforme (GBM). Oral NFV is a standard therapy for patients with HIV a...
What is the current status of trial NCT01020292?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2009-04. Estimated completion is 2017-12.
What conditions does trial NCT01020292 study?
This clinical trial studies the following conditions: Glioma.
What interventions are being tested in trial NCT01020292?
The interventions under investigation include: Nelfinavir (DRUG).
Who is sponsoring clinical trial NCT01020292?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01020292 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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