Clinical trial · Interventional
ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases
NCT02048059CI-TRIAL-00043618completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANG1005 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ANG1005
- description
- 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.
- interventionNames
- Drug: ANG1005
Primary outcomes (1)
- measure
- Intracranial objective response rate (iORR)
- timeFrame
- Upon enrollment through end of study period (1 year after last patient is enrolled)
Secondary outcomes (10)
- measure
- Duration of intracranial objective response
- timeFrame
- Upon enrollment through end of study period (1 year after last patient is enrolled)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.