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A Safety Study of SGN-LIV1A in Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01969643
Recruitment Status : Recruiting
First Posted : October 25, 2013
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE October 25, 2013
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE October 22, 2013
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
Change History Complete list of historical versions of study NCT01969643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Blood concentrations of SGN-LIV1A and metabolites [ Time Frame: Through 3 weeks after dosing; up to approximately 2 years ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
  • Objective response rate (ORR) [ Time Frame: Through 1 month following last dose; up to approximately 2 years ]
    ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) per RECIST v1.1.
  • Duration of response (DOR) [ Time Frame: Up to approximately 3 years ]
    DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (clinical progression or progressive disease (PD) per RECIST v1.1).
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 8 years ]
    PFS is defined as the time from start of study treatment to first documentation of tumor progression (clinical progression or PD per RECIST v1.1).
  • Overall survival (OS) [ Time Frame: Up to approximately 8 years ]
    OS is defined as the time from start of study treatment to date of death due to any cause.
  • PFS relative to prior therapy [ Time Frame: Up to approximately 8 years ]
    The PFS ratio is defined for each subject as the ratio of the current PFS and the PFS achieved on their most recent therapy where they experienced progression.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2013)
  • Blood concentrations of SGN-LIV1A and metabolites [ Time Frame: Through 3 weeks after dosing ]
  • Incidence of antitherapeutic antibodies [ Time Frame: Through 1 month following last dose ]
  • Objective response rate [ Time Frame: Through 1 month following last dose ]
  • Duration of response [ Time Frame: Up to approximately 3 years ]
  • Progression-free survival [ Time Frame: Up to approximately 3 years ]
  • Progression-free survival relative to prior therapy [ Time Frame: Up to approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of SGN-LIV1A in Breast Cancer Patients
Official Title  ICMJE A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer
Brief Summary This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given alone or in combination with trastuzumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: SGN-LIV1A
    SGN-LIV1A will be given by intravenous infusion (into the vein; IV)
  • Drug: Trastuzumab
    Trastuzumab will be given by IV every 3 weeks at a dose of 6 mg/kg (the first dose will be 8 mg/kg)
    Other Name: Herceptin
Study Arms  ICMJE
  • Experimental: SGN-LIV1A Dose Escalation
    Intervention: Drug: SGN-LIV1A
  • Experimental: SGN-LIV1A + Trastuzumab
    Interventions:
    • Drug: SGN-LIV1A
    • Drug: Trastuzumab
  • Experimental: SGN-LIV1A
    SGN-LIV1A will be given at the recommended dose (at or below the monotherapy MTD determined in the SGN-LIV1A dose escalation arm).
    Intervention: Drug: SGN-LIV1A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2019)
378
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2013)
51
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
  • One of the following:

    • Part A) Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
    • Part B) Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
    • Part C) Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
    • Part D) Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
    • Part E) HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
  • Parts A, B, C, and D: Newly obtained tumor tissue biopsy and archived tumor tissue, if available, must be collected for central pathology determination of LIV-1 expression
  • Part E: Archival baseline tumor sample is required; a fresh biopsy sample may be submitted in place of an archival sample if medically feasible.
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Combination Arm: adequate heart function

Exclusion Criteria:

  • Pre-existing neuropathy Grade 2 or higher
  • Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Part E: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
  • Prior treatment with SGN-LIV1A or prior treatment with an MMAE-containing therapy
  • Combination Arm: hypersensitivity to trastuzumab
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01969643
Other Study ID Numbers  ICMJE SGNLVA-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phillip Garfin, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date September 3, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP