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NCT01931098 · ClinicalTrials.gov registry record · Phase 2
Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01931098: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01931098 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01931098, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
Background: Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat lung cancer. Both topotecan and pazopanib have individually been used to treat patients with glioblastoma and some anti-tumor activity has been found. Researchers want to see if these two drugs together may be able to help people with glioblastoma. Objectives: To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the safety of this drug combination. Eligibility: Adults at least 18 years old whose glioblastoma has returned after treatment. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Brain computed tomography (CT) or magnetic resonance imaging (MRI) For these, participants lay in a machine that takes pictures. Chest CT scan or x-ray Heart electrocardiogram (EKG) A questionnaire about quality of life Participants will be assigned to a study group. Participants will take the study drugs for 28-day cycles for up to 1 year. They will take capsules of topotecan by mouth once every day. They will take tablets of pazopanib by mouth once every day. Participants will write in a diary the times they take the study drugs. Participants will have several study visits during each cycle. These may include Blood pressure measurement Blood and urine tests EKG Physical exam and/or neurological exam Brain MRI or CT scan to check the status of the disease A symptom questionnaire At the end of treatment, participants will have a physical exam. They may have blood drawn. Participants will have follow-up calls once every 3 months to check.
Primary Outcome
PFS was evaluated using the Kaplan-Meier product-limit survival curve methodology. For participants with no prior bevacizumab exposure, PFS is defined as 2 or more participants who are progression free at 6 months. For participants with prior bevacizumab exposure, PFS is defined as 1 or more participants who are progression free at 3 months. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) or clear worsening
Interventions
- DRUG topotecan
- DRUG pazopanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-12-10 |
| Est. Completion | 2019-09-12 |
| Phase | Phase 2 |
What the finished NCT01931098 record still lists
NCT01931098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which topotecan is the first listed.
NCT01931098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01931098 about?
NCT01931098 is a clinical study titled "Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab". Background: Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat lung cancer. Both topotecan and pazopanib have individually been used to treat patients with glioblastom...
What is the current status of trial NCT01931098?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2015-12-10. Estimated completion is 2019-09-12.
What interventions are being tested in trial NCT01931098?
The interventions under investigation include: topotecan (DRUG), pazopanib (DRUG).
Who is sponsoring clinical trial NCT01931098?
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 NCT01931098's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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