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Sponsored by: |
Angiochem Inc |
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Information provided by: | Angiochem Inc |
ClinicalTrials.gov Identifier: | NCT00539344 |
This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the safety, tolerability, and PK of ANG1005 in patients with recurrent or progressive malignant glioma. ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle). Each patient will participate in only 1 dose group and will receive up to 6 cycles of treatment provided there is no evidence of tumor progression, there is recovery to ≤Grade 1 or baseline nonhematologic, ANG1005-related toxicity (except alopecia), the absolute neutrophil count is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.
Condition | Intervention | Phase |
---|---|---|
Recurrent or Progressive Malignant Glioma |
Drug: ANG1005 |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Malignant Glioma |
Estimated Enrollment: | 70 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ANG1005
IV infusion once every 21 days
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This is a phase 1, multi-centre, sequential cohort, open-label, dose-escalation study of the safety, tolerability, and PK of ANG1005 in patients with recurrent or progressive malignant glioma. ANG1005 will be given by IV infusion once every 21 days (1 treatment cycle). Each patient will participate in only 1 dose group and will receive up to 6 cycles. Patients may receive additional cycles of ANG1005 if there is no evidence of tumor progression, there is recovery to ≤Grade 1 or baseline nonhematologic, ANG1005-related toxicity (except alopecia), the absolute neutrophil count is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L.
Initially, cohorts of 1 - 3 patients will be enrolled into each dose group. Dose escalation by dose doubling will be done for the first 3 dose groups followed by a modified Fibonacci dose escalation scheme with increases of 67%, 50%, 40% and 33% thereafter. If > 1 patient in a cohort experience an emergent ≥ Grade 2 drug-related toxicity during the first treatment cycle, then a minimum of 3 patients will be enrolled into that, and all subsequent cohort(s) and dose doubling will be stopped if applicable.
If > 1 patient in a cohort experience a dose limiting toxicity (DLT) during the first treatment cycle, defined as any of the following that are both treatment-emergent and at least possibly related to ANG1005: i) Any Grade 3 or 4 nonhematologic toxicity, ii) Febrile neutropenia, iii) Grade 4 neutropenia of ≥7 days duration, and/or iv) Any Grade 4 thrombocytopenia, then dose escalation will stop and prior doses will be explored as the maximum tolerated dose (MTD), that dose-level at which ≤1 of 6 patients in a cohort develop an emergent DLT).
Once the MTD is established, approximately 14 patients will be enrolled at that dose-level in order to further assess the safety and tolerability of ANG1005, the PK profile of ANG1005 at the MTD, and the preliminary anti-tumor activity of ANG1005 in patients with malignant glioma.
Approximately 8 additional patients who are scheduled for debulking surgery for recurrent disease may be enrolled into a separate sub-study to obtain preliminary information about whether or not ANG1005 crosses the blood-brain barrier into malignant glioma tumors. These patients will receive ANG1005 prior to surgery at the dose level established to be safe and tolerable at that time and may continue to receive additional cycles of ANG1005 following surgery, if appropriate.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paula Bento | 1-877-322-6446 | pbento@angiochem.com |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Brenna McNamara 617-632-3780 margaretb_mcnamara@dfci.harvard.edu | |
Principal Investigator: Jan Drappatz, MD | |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Amy Williamson 313-916-3731 awillia12@hfhs.org | |
Principal Investigator: Tom Mikkelsen, MD | |
United States, New York | |
Irving Comprehensive Cancer Center, Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Mahogany Ayele 212-305-7256 maa2133@columbia.edu | |
Principal Investigator: Steven Rosenfeld, MD | |
United States, Texas | |
University of Texas, MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Kathy Hunter 713-745-5769 kuhunter@mdanderson.org | |
Principal Investigator: Morris Groves, MD | |
UT Health Science Center at the Cancer Therapy and Research Center (CTRC) | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Cherie J. Noles, CCRP 210-450-5964 nolesc@uthscsa.edu | |
Principal Investigator: John Sarantopoulos, MD | |
United States, Virginia | |
University of Virginia Health System | Recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Yuliya Havaleshko 434-243-9900 yih8f@virginia.edu | |
Principal Investigator: David Schiff, MD |
Responsible Party: | Angiochem Inc. ( Jean-Paul Castaigne, MD - President & CEO ) |
Study ID Numbers: | ANG1005-CLN-01, FDA |
Study First Received: | October 2, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00539344 |
Health Authority: | United States: Food and Drug Administration |
Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |