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NCT01290263 · ClinicalTrials.gov registry record · Phase 1
Amgen 386 for Recurrent Glioblastoma
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01290263 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 48 participants.
The verdict
NCT01290263, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
Primary Objectives Cohort A -- monotherapy: To determine the efficacy of AMG 386 in participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6) Cohort B - combination therapy: Phase I To determine the maximum tolerated dose of AMG 386 in combination with bevacizumab given at 10mg/kg every 2 weeks in participants with recurrent glioblastoma. Phase II To determine the efficacy of AMG 386 plus bevacizumab in participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6). Secondary Objectives: To evaluate radiographic response in both cohort populations. To evaluate overall survival in both cohort populations. To assess time-to-progression in both cohort populations. To investigate the safety profile in both cohort populations. Exploratory Objectives: To evaluate expression of factors associated with tumor angiogenesis using a multiples cytokine assay among participants undergoing therapy with AMG 386 with response to therapy and development of resistance. This is an open-label Phase I/II study of AMG 386 monotherapy and AMG 386 in combination with bevacizumab. Two cohorts will accrue and will be assessed sequentially. Each cohort will enroll participants with recurrent GBM. Cohort A will assess recurrent GBM participants who receive AMG 386 monotherapy at 30 g/kg every week. (Cohort A initially accrued at a dose of 15mg/kg, but this was increased to 30 mg/kg every week following an amendment). Cohort B will assess recurrent GBM participants who receive weekly AMG 386 plus bi-weekly bevacizumab (10mg/kg). Cohort B will start with a Phase I component to determine the MTD of AMG 386 that is safe when used in combination with bevacizumab. AMG 386 is administered intravenously, and, when used in combination with intravenous bevacizumab, will be administered first. Patients will be required to come to the clinic weekly for study drug administration. For study purposes, a cycle of t
Interventions
- DRUG Bevacizumab
- DRUG Amgen 386
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2010-12 |
| Est. Completion | 2017-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01290263
The ClinicalTrials.gov registry entry for NCT01290263 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT01290263 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01290263 about?
NCT01290263 is a clinical study titled "Amgen 386 for Recurrent Glioblastoma". Primary Objectives Cohort A -- monotherapy: To determine the efficacy of AMG 386 in participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6) Cohort B - combination therapy: Phase I To determine the maximum tolerated dose of AMG 386 in combination wit...
What is the current status of trial NCT01290263?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2010-12. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01290263?
The interventions under investigation include: Bevacizumab (DRUG), Amgen 386 (DRUG).
Who is sponsoring clinical trial NCT01290263?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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