A Phase 2 interventional study of ANG1005 in Breast Cancer and Brain Metastases, sponsored by Angiochem Inc. Completed at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Angiochem Inc · Phase 2, Interventional, and Treatment
This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 72 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Angiochem Inc is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received ANG1005 intravenously (IV) at a dose of 600 mg/m\^2 on Day 1 of each 21-day cycle. ANG1005 will be administered for up to a maximum of one year, or until disease progression or adverse events (AE) that are not tolerated.
Drug: ANG1005
Intracranial objective response rate (iORR)
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Duration of intracranial objective response
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Median intracranial progression-free survival (PFS)
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial PFS rates at 3, 6 and 12 months
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
6-month overall survival (OS) rate
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial objective response rate (eORR) and duration of response
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Number of Patients with adverse events
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Plasma pharmacokinetics of ANG1005
To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)
Time frame: On Day 1 of Cycles 1 and 3
Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial clinical benefit rate (iCBR) at 3 and 6 months
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Potential immunogenicity of ANG1005
Time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Angiochem Inc