Overview

This trial is active, not recruiting.

Conditions breast cancer, brain metastases
Treatment ang1005
Phase phase 2
Sponsor Angiochem Inc
Start date April 2014
End date September 2016
Trial size 56 participants
Trial identifier NCT02048059, ANG1005-CLN-04

Summary

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.

United States Maryland
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ang1005

Primary Outcomes

Measure
Intracranial objective response rate
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Secondary Outcomes

Measure
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 rate
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled
Extracranial ORR
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
Pharmacokinetics
time frame: On Day 1 of Cycles 1 and 3
Duration of Response
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)
Intracranial clinical benefit at 3 and 6 months
time frame: Upon enrollment through end of study period (1 year after last patient is enrolled)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. ≥ 18 years old 2. Breast cancer 3. Recurrent brain metastases from breast cancer 4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm) 5. Neurologically stable 6. Karnofsky Performance Status (KPS) score ≥ 70 Exclusion Criteria: 1. Prior treatment with ANG1005/GRN1005 2. Pregnancy or lactation 3. Inadequate bone marrow reserve 4. Any evidence of severe or uncontrolled diseases 5. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV 6. CNS disease requiring immediate neurosurgery intervention (e.g., resection, shunt placement, etc.) 7. Known allergy to paclitaxel or any of its components

Additional Information

Official title A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
Description See above.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Angiochem Inc.
Location data was received from the National Cancer Institute and was last updated in June 2016.