A Phase 1, Open-Label, Dose Escalation Study of ANG1005 in Patients With Advanced Solid Tumors and Metastatic Brain Cancer

Completed · Phase 1

Conditions studied: Advanced Solid Tumors With and Without Brain Metastases

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 solid tumors (with or without brain metastases). 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

NCT00539383

Run by

Angiochem Inc

People needed

56

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 or cytologically confirmed metastatic or advance-stage solid tumor that has progressed following standard therapy or for which, 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
• Patients enrolled into the expanded MTD cohort must have shown unequivocal evidence of brain metastases
• 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 RECIST criteria; patients with brain metastases must have at least one measurable lesion in the brain, according to RECIST 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
• Treatment 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, 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

• Gabrail Cancer Center — Canton, Ohio, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• UT Health Science Center, Cancer Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.