Clinical Trials

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SCCA Breast Cancer Clinical Trials

SGN-LIV1A for Breast Cancer
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer
Status Conditions Phase Study ID
Recruiting Breast Cancer Phase I NCT01969643
Summary

This study is being conducted to examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer, and to find the highest dose of the drug that can be given without unacceptable side effects. Other goals of the trial are to find out if SGN-LIV1A has any antitumor effects, to learn about the pharmacokinetics of SGN-LIV1A, and to explore the relationship between antigen expression and SGN-LIV1A effects.


Investigator
Jennifer M. Specht, MD
Location    
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of metastatic disease
  • One of the following: a) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the metastatic setting; or b) ER- and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the metastatic setting and are no longer a candidate for hormonal therapy
  • Positive for LIV-1 expression by central pathology review on newly obtained tumor tissue biopsy
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1
Exclusions (conditions that would prevent participation in this study)
  • Pre-existing neuropathy Grade 2 or higher
  • Malignant CNS disease that has not been definitively treated
  • P-gp inducers/inhibitors of strong CYP3A inducers/inhibitors within 2 weeks before first dose
Last Updated
December 26, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.