CompletedPhase 2

ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

United States72 participantsStarted 2014-04

Plain-language 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.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. ≥ 18 years old
✓. Breast cancer
✓. Recurrent brain metastases from breast cancer
✓. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5 cm)
✓. Neurologically stable
✓. Karnofsky Performance Status (KPS) score ≥ 70
✓. Adequate hematology and serum chemistry laboratory test results
✓. Expected survival of ≥ 3 months

✕. Prior treatment with ANG1005/GRN1005
✕. Evidence of symptomatic intracranial hemorrhage
✕. Pregnancy or lactation
✕. Inadequate bone marrow reserve
✕. Any evidence of severe or uncontrolled diseases
✕. Patients with the presence of an infection including abscess or fistulae, or known infection with hepatitis B or C or HIV
✕. History of interstitial lung disease or evidence of clinically significant interstitial lung disease
✕. Severe cardiac conduction disturbance

Intracranial objective response rate (iORR)

Timeframe: Upon enrollment through end of study period (1 year after last patient is enrolled)

NCT IDNCT02048059

SponsorAngiochem Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03