Status:
TERMINATED
A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Lead Sponsor:
AbbVie
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study con...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.
- Advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent
- TNBC is defined as:
- \<1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
- Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal function.
Exclusion
- Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
- Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
- Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03316794
Start Date
January 4 2018
End Date
October 5 2018
Last Update
December 17 2018
Active Locations (8)
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1
University of Chicago /ID# 169231
Chicago, Illinois, United States, 60637-1443
2
Washington University School /ID# 169177
St Louis, Missouri, United States, 63108
3
Memorial Sloan Kettering /ID# 201016
New York, New York, United States, 10065
4
Gabrail Cancer Center Research /ID# 168756
Canton, Ohio, United States, 44718