Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2013-10-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
ANG1005 administered to bevacizumab-naive recurrent GBM participants
ANG1005
ANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
Arm 2
ANG1005, with or without bevacizumab, administered to bevacizumab-refractory recurrent GBM participants
ANG1005
ANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
Bevacizumab
For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
Arm 3
ANG1005 administered to recurrent WHO Grade III anaplastic glioma participants
ANG1005
ANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
Interventions
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ANG1005
ANG1005 at a starting dose of 650 mg/m\^2 or 600 mg/m\^2 by intravenous infusion once every 3 weeks
Bevacizumab
For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. GBM and GBM variants, WHO Grade III anaplastic glioma diagnosis confirmed
3. Radiologically confirmed recurrent and bi-dimensionally measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria
4. Neurologically stable
5. For bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy
6. Karnofsky performance status (KPS) ≥ 80
7. Expected survival of at least 3 months
Exclusion Criteria
2. Previous ANG1005/GRN1005 treatment
3. Radiotherapy within 3 months.
4. Therapy with bevacizumab within 4 weeks prior to Day 1 of treatment for recurrent WHO grade III anaplastic glioma patients (Arm 3)
5. Evidence of significant intracranial hemorrhage
6. Previous taxane treatment
7. Prior therapy with bevacizumab for bevacizumab-naïve patients (Arm 1)
8. NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 Grade ≥ 2 neuropathy
9. Inadequate bone marrow reserve
10. Any evidence of severe or uncontrolled diseases
11. Participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis C or B or HIV
12. Known severe hypersensitivity or allergy to paclitaxel or any of its components
18 Years
ALL
No
Sponsors
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Angiochem Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Betty Lawrence
Role: STUDY_DIRECTOR
Angiochem Inc
Locations
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Moores UC San Diego Cancer Center
La Jolla, California, United States
Northwestern University
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Cleveland Clinic
Cleveland, Ohio, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
Univeristy of Texas Health Science Center in San Antonio
San Antonio, Texas, United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Dmello C, Brenner A, Piccioni D, Wen PY, Drappatz J, Mrugala M, Lewis LD, Schiff D, Fadul CE, Chamberlain M, Kesari S, Ahluwalia M, Ghosh D, Sonabend AM, Kumthekar P. Phase II trial of blood-brain barrier permeable peptide-paclitaxel conjugate ANG1005 in patients with recurrent high-grade glioma. Neurooncol Adv. 2024 Dec 14;6(1):vdae186. doi: 10.1093/noajnl/vdae186. eCollection 2024 Jan-Dec.
Related Links
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A Phase I sudy of ANG1005 (GRN1005) in recurrent malignant glioma
Other Identifiers
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ANG1005-CLN-03
Identifier Type: -
Identifier Source: org_study_id
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