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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Angiochem Inc

Criteria

Inclusion Criteria:

1. Written informed consent

2. Histologically confirmed malignant glioma

3. Radiologically confirmed progression of malignant glioma

4. Patients must, in the opinion of the investigator, be ineligible for current standard of care treatment

5. No evidence of acute intracranial/intratumoral hemorrhage

6. Male and female patients

7. Age ≥18 years

8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

9. An expected survival of at least 3 months

10. Measurable disease according to Macdonald response criteria

11. 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

Exclusion Criteria:

1. 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

2. Pregnant or lactating females

3. Any acute viral, bacterial, or fungal infection that requires parenteral therapy within 14 days prior to study treatment

4. Known severe hypersensitivity to paclitaxel

5. Severe toxicity with previous taxane treatment

6. Patients being treated with P450 CYP 3A4 or CYP 2C8 enzyme-inducing anti-convulsant drugs within 14 days prior to treatment with study drug

7. Patients with inadequate hematological, liver, and renal function

8. Known or suspected acute or chronic active Hepatitis B, or Hepatitis C or HIV/AIDS

9. 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

10. Evidence of persistent Grade 2 or greater neurotoxicity