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NCT01721577 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of AXL1717 in the Treatment of Recurrent Malignant Astrocytomas
A Phase 1 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01721577: Clinical Trial Phase 1 study, sponsored by Rush University Medical Center.
NCT01721577 is a Phase 1 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721577, a Phase 1 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days during cycle 5). The following cycle will not be started until the treatment continuation criteria are fulfilled. Concomitant supportive therapies will be allowed.
Primary Outcome
To determine the recommended phase II dose (RPTD) of AXL1717 in recurrent malignant astrocytomas defined as the highest dose level without DLT (Dose Limiting Toxicity) or with maximally one DLT out of 6 patients will be the RPTD.
Interventions
- DRUG AXL1717
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-12 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
Why NCT01721577 stopped before completion
NCT01721577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which AXL1717 is the first listed.
NCT01721577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721577 about?
NCT01721577 is a clinical study titled "Phase I/II Trial of AXL1717 in the Treatment of Recurrent Malignant Astrocytomas". This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas (glioblastoma, gliosarcoma, ana...
What is the current status of trial NCT01721577?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2012-12. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01721577?
The interventions under investigation include: AXL1717 (DRUG).
Who is sponsoring clinical trial NCT01721577?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01721577's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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