Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01017653 · ClinicalTrials.gov registry record · Phase 2
Panitumumab and Irinotecan for Malignant Gliomas
A Phase 2 study, sponsored by Annick Desjardins.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01017653 is a Phase 2 study that was terminated before completion, run by Annick Desjardins. The registered enrollment target is 16 participants.
The verdict
NCT01017653, a Phase 2 study, was terminated before completion, sponsored by Annick Desjardins.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a phase II study of the combination of panitumumab with irinotecan in malignant glioma patients. The primary objective of the study is to determine the activity of the combination of panitumumab with irinotecan as measured by 6-month progression-free survival. Secondary objectives include the following- to determine the safety of panitumumab in combination with irinotecan in patients with malignant glioma; to determine the effect of panitumumab in combination with irinotecan on corticosteroid dose for each patient; to explore any relationship between epidermal growth factor receptor (EGF-R) mutational analysis and efficacy or toxicity; and, to determine the response rate and overall survival of recurrent glioblastoma (GBM) patients treated with panitumumab in combination with irinotecan. The patients will have histologically documented grade 4 malignant gliomas (glioblastoma multiforme or gliosarcoma) that have failed at least one prior chemotherapy regimen and all patients will have received radiation therapy. This study will investigate second or greater line of therapy for recurrent grade 4 malignant glioma. The patient population will include 32 patients. The patients will undergo a baseline magnetic resonance imaging (MRI) as well as a MRI after every six-week cycle to determine response and progression. After 16 patients with recurrent GBM are treated, an interim analysis will be conducted. The most common side effects associated with panitumumab have been dermatological (skin) problems such as erythema (redness of the skin), acneiform rash (skin eruptions of the face), skin exfoliation, pruritus (itching), skin fissures (skin tears), xerosis (dryness of the eye, skin, or mouth), and rash. The most common side effects associated with irinotecan have been decreased blood counts of platelets (increased risk of bleeding), white blood cells (increased risk of infection), red blood cells (anemia); diarrhea, constipation, nausea, vomiting, tiredness, fever
Interventions
- DRUG Irinotecan
- DRUG Panitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01017653
The ClinicalTrials.gov registry entry for NCT01017653 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Annick Desjardins, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Irinotecan is the first listed.
NCT01017653 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01017653 about?
NCT01017653 is a clinical study titled "Panitumumab and Irinotecan for Malignant Gliomas". This is a phase II study of the combination of panitumumab with irinotecan in malignant glioma patients. The primary objective of the study is to determine the activity of the combination of panitumumab with irinotecan as measured by 6-month progression-free survival. Secondary objectives include th...
What is the current status of trial NCT01017653?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2010-02. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01017653?
The interventions under investigation include: Irinotecan (DRUG), Panitumumab (DRUG).
Who is sponsoring clinical trial NCT01017653?
This trial is sponsored by Annick Desjardins, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.