MDACC Study Summary 2007-0699 (Archived)

Study Summary
No. 2007-0699:.......Solid Tumors......Razelle Kurzrock......Investigational Cancer Therapeutics

Study Summary Title



Study Summary Number:	2007-0699

Study Title:	A Phase I, Open-Label, Dose Escalation Study of ANG1005 in Patients with Advanced Solid Tumors and Metastatic Brain Cancer (ANG1005-CLN-02)

Physician

New Patient Referral



Name:	Razelle Kurzrock	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-563-1930 Contact us about clinical trials

General Information



Disease Group:	Solid Tumors	Supported By:	Angiochem, Inc

Phase of Study:	Phase I	Return Visit:	During Cycle 2, patients will return to clinic on Days 2, 8 and 15. For Cycle 2 and beyond, patients will return on Days 1, 8, 15 and 21.

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 that can be given to patients with solid tumors. The safety of this drug will also be studied. This is the first time this drug has been given to humans.

Study Objectives / Outcomes

Primary Objectives:

To characterize the safety and tolerability of intravenously administered ANG1005 in patients with advanced solid tumors and metastatic brain cancer
To identify the maximum tolerated dose (MTD) of ANG1005 in patients with advanced solid tumors and metastatic brain cancer.

Secondary Objectives:

To examine the pharmacokinetics of ANG1005.
To obtain preliminary information the antitumor activity of ANG1005 in patients with metaststic brain cancer
To confirm the safety and tolerability of ANG1005 at the MTD
To assess the immunogenicity of ANG1005
To obtain preliminary information about whether or not ANG1005 crosses the blood- brain barrier into metastatic brain tumors

Study Status Information



Study Activation / Registration Date:	11/14/2007

IRB Review and Approval Date:	11/14/2007

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	64

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) Patients must meet the following criteria within 21 days of study entry (Cycle 1, Day 1) unless otherwise specified:

2) Histologically or cytologically confirmed (at any time prior to study entry) metastatic or advance-stage solid tumor (e.g. nonsmall cell lung cancer, breast cancer, pancreatic cancer, etc.) that has progressed following standard therapy or for whom, in the opinion of the investigator, no standard effective therapy is available. Patients without brain metastases may be enrolled into the dose-escalation part of the study after discussion with the Study Medical Monitor. All patients enrolled into the expanded MTD cohort must have brain metastases.

3) Patients enrolled into the expanded MTD cohort must have shown unequivocal evidence of tumor progression in the CNS by CT or MRI at any time prior to study entry.

4) Male and female patients aged >/= 18 years.

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

6) An expected survival of at least 3 months

7) Measurable disease according to RECIST criteria; patients with brain metastases must have at least one measurable lesion, according to RECIST criteria, in the brain.

8) 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 adminisration. 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), biologic therapy, immunotherapy, or investigational agents within 4 weeks before the first dose of study drug.

2) Pregnant or lactating females [all patients must practice adequate birth control and females of child-bearing potential must have a negative serum beta-HCG pregnancy test (within Day -7 to Day 0)]. Results must be negative before initiation of each cycle of treatment.

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, 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) Patients with 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*; (*Patients may be transfused with packed red blood cells prior to ANG1005 infusion, if clinically warranted. Post-transfusion hematologic assessments may qualify the patient for participation.)

8) Patients with any of the following serum chemistry abnormalities at baseline: total bilirubin > 1.5 times the upper limit of the reference range (ULRR) in the absence of liver metastases or >2.5 x the ULRR in the presence of liver metastases; AST or ALT > 2.5 x the ULRR in the absence of liver metastases or > 5 x the ULRR in the presence of liver metastases; serum calcium above ULRR; and 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 laboaratory 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: NCT00539383
Study Information on Clinical Trials Registry (clinicaltrials.gov)