ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Breast Cancer Clinical Trial

Official title:

A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02048059
• Other study ID #: ANG1005-CLN-04
• Status: Completed
• Phase: Phase 2
• Start date: April 2014
• Est. completion date: September 2017

Study information

• Verified date: February 2020
• Source: Angiochem Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

7. Adequate hematology and serum chemistry laboratory test results

8. Expected survival of = 3 months

Exclusion Criteria:

1. Prior treatment with ANG1005/GRN1005

2. Evidence of symptomatic intracranial hemorrhage

3. Pregnancy or lactation

4. Inadequate bone marrow reserve

5. Any evidence of severe or uncontrolled diseases

6. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV

7. History of interstitial lung disease or evidence of clinically significant interstitial lung disease

8. Severe cardiac conduction disturbance

9. Central nervous system (CNS) disease requiring immediate neurosurgery intervention

10. Known severe hypersensitivity or allergy to paclitaxel or any of its components

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Drug:
• ANG1005

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	GRU Cancer Center - Georgia Regents University	Augusta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of Maryland - Greenebaum Cancer Center	Baltimore	Maryland
United States	National Cancer Institute	Bethesda	Maryland
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Long Islan Brain Tumor Center at Neurological Surgery P.C.	Commack	New York
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	MD Anderson Cancer Center	Houston	Texas
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	University of California - LAC Medical Center	Los Angeles	California
United States	University of Southern California - Norris Comprehensive Cancer Center	Los Angeles	California
United States	UC - Irvine Chao Family Comprehensive Cancer Center	Orange	California
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Univeristy of Texas Health Science Center in San Antonio	San Antonio	Texas
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Angiochem Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intracranial objective response rate (iORR)		Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Duration of intracranial objective response		Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Median intracranial progression-free survival (PFS)		Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Intracranial PFS rates at 3, 6 and 12 months		Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	6-month overall survival (OS) rate		Upon enrollment through end of study period (1 year after last patient is enrolled
Secondary	Extracranial objective response rate (eORR) and duration of response		Upon enrollment through end of study period (1 year after last patient is enrolled
Secondary	Number of Patients with adverse events		Upon enrollment through end of study period (1 year after last patient is enrolled
Secondary	Plasma pharmacokinetics of ANG1005	To determine the drug concentration and distribution in the plasma. (AUC, Cmax, T1/2)	On Day 1 of Cycles 1 and 3
Secondary	Intracranial ORR by modified Response Assessment in Neuro-Oncology (RANO) criteria		Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Intracranial clinical benefit rate (iCBR) at 3 and 6 months		Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary	Potential immunogenicity of ANG1005		Upon enrollment through end of study period (1 year after last patient is enrolled)

External Links

•   Safety, pharmacokinetics, and activity of GRN1005, a novel conjugate of angiopep-2, a peptide facilitating brain penetration, and paclitaxel, in patients with advanced solid tumors