A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Malignant Glioma

Completed · Phase 1

Conditions studied: Recurrent or Progressive Malignant Glioma

In brief

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.

Key facts

Study ID: NCT00539344
Run by: Angiochem Inc
People needed: 63
Starts: 2007-10-01
Expected to finish: 2010-03-01
Last updated by the study team: 2014-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Written informed consent
Histologically confirmed malignant glioma
Radiologically confirmed progression of malignant glioma
Patients must, in the opinion of the investigator, be ineligible for current standard of care treatment
No evidence of acute intracranial/intratumoral hemorrhage
Male and female patients
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
An expected survival of at least 3 months
Measurable disease according to Macdonald response criteria
Male and female subjects who are not surgically sterile or post-menopausal must agree to use reliable methods of birth control for the duration of the study and for 90 days after the last dose of study drug administration; male partners of female subjects should use condoms for the duration of the study, and for 90 days after the last dose of study drug administration

You may not qualify if…

Chemotherapy, radiotherapy (except palliative radiation delivered to <20% of bone marrow), or investigational agents within 4 weeks before the first dose of study drug. Biologic therapy (such as 13-cis-retinoic acid, thalidomide, tamoxifen, celebrex, erlotinib, imatinib, vorinostat, and lapatinib) and immunotherapy (such as interferon a or b, cdx-110 (EGFR vIII vaccine), interleukin 2, thalidomide) within 1 week before the first dose of study drug. Bevacizumab within 6 weeks before the first dose of study drug
Pregnant or lactating females
Any acute viral, bacterial, or fungal infection that requires parenteral therapy within 14 days prior to study treatment
Known severe hypersensitivity to paclitaxel
Severe toxicity with previous taxane treatment
Patients being treated with P450 CYP 3A4 or CYP 2C8 enzyme-inducing anti-convulsant drugs within 14 days prior to treatment with study drug
Patients with inadequate hematological, liver, and renal function
Known or suspected acute or chronic active Hepatitis B, or Hepatitis C or HIV/AIDS
Patients with unstable or uncompensated respiratory, cardiac, hepatic or renal disease or any other organ system dysfunction, medical condition, or laboratory abnormality which, in the opinion of the investigator, would either comprise the patient's safety or interfere with the evaluation of the test material
Evidence of persistent Grade 2 or greater neurotoxicity

Where it is running

Dana Farber Cancer Institute — Boston, Massachusetts, United States
Henry Ford Health System — Detroit, Michigan, United States
Irving Comprehensive Cancer Center, Columbia University Medical Center — New York, New York, United States
University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
UT Health Science Center at the Cancer Therapy and Research Center (CTRC) — San Antonio, Texas, United States
University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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