MDACC Study Summary 2007-0931

Study Summary
No. 2007-0931:.......Brain; CNS......Morris D. Groves......Neuro Oncology

Study Summary Title



Study Summary Number:	2007-0931

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

Physician

New Patient Referral



Name:	Morris D. Groves	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Neuro Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2883 Contact us about clinical trials

General Information



Disease Group:	Brain CNS	Supported By:	Angiochem Inc.

Phase of Study:	Phase I	Return Visit:	every 3 weeks

Treatment Agents:	ANG1005	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest tolerable dose of ANG1005. The safety of this drug will also be studied. ANG1005 is in the early stages of being tested in humans.

Study Objectives / Outcomes

1. Primary Objectives

To characterize the safety and tolerability of intravenously administered ANG1005 in patients with malignant glioma.
To identify the maximum tolerated dose (MTD) of ANG1005 in patients with malignant glioma.

2. Secondary Objectives

To examine the pharmacokinetics (PK) of ANG1005.
To confirm the safety and tolerability of ANG1005 at the MTD.
To assess the immunogenicity of ANG1005.
To obtain preliminary information the antitumor activity of ANG1005 in patients with malignant glioma.
To obtain preliminary information about whether or not ANG1005 crosses the blood- brain barrier into malignant glioma tumors (Sub-study).

Study Status Information



Study Activation / Registration Date:	04/02/2008

IRB Review and Approval Date:	04/02/2008

Study Type:	Phase I

Recruitment Status:	Closed

Projected Accrual:	70

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically confirmed (at any time prior to study entry) WHO Graades II, II, or IV malignant glioma (glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma).

2) Radiologically confirmed progression (at any time prior to study entry) of malignant glioma (following (i) resection, (ii) first line treatment or (iii) current standard of care). Patients must have shown unequivocal radiographic evidence of tumor progression by MRI scan while on a fixed (stable) dose of steroids for at least 5 days. A baseline MRI must be obtained within 21 days of the first dose of ANG1005 (Cycle 1, Day 1).

3) Patients must, in the opinion of the Investigator, be ineligible for current standard of care treatment.

4) No evidence of acute intracranial/intratumoral hemorrhage.

5) Male and female patients.

6) Age >/=18 years.

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

8) An expected survival of at least 3 months.

9) Measurable disease according to Macdonald response criteria, i.e., patients must have at least one measurable lesion defined as a lesion with clear borders that can be accurately measured in two dimensions with one diameter >/= 1.0 cm (10 mm).

10) Male and female subjects who are not surgically sterile or post-menopausal (at least 24 months after the last menstrual period) must agree to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermacide) 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.

11) Written informed consent.

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 lapatanib) 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 (Cycle 1, Day 1).

4) Known severe hypersensitivity to paclitaxel.

5) Severe toxicity with previous taxane treatment.

6) Treatment with P450 CYP 3A4 or CYP 2C8 enzyme-inducing anti-convulsant drugs, including but not limited to phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone and oxcarbazepine within 14 days prior to treatment with study drug (Cycle 1 Day 1).

7) Any of the following hematologic abnormalities at baseline: Hemoglobin < 9.0 g/dL; Absolute neutrophil count < 1.5 x 10^9/L; Platelet count < 100 x 10^9/L

8) Any of the following serum chemistry abnormalities at baseline:Total bilirubin > 1.5 times the upper limit of the reference range (ULRR); AST or ALT > 2.5 times the ULRR; Serum calcium above ULRR; Creatinine clearance (estimated) < 60 mL/min

9) Known or suspected acute or chronic active Hepatitis B or Hepatitis C or HIV/AIDS.

10) 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.

11) Evidence of persistent Grade 2 or greater neurotoxicity.

Links

Registration Number: NCT00539344
Study Information on Clinical Trials Registry (clinicaltrials.gov)