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Trial record 1 of 1 for:    M16-735 | Breast Cancer
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A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)

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ClinicalTrials.gov Identifier: NCT03316794
Recruitment Status : Terminated (Strategic considerations)
First Posted : October 20, 2017
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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 consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: SC-005 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Actual Study Start Date : January 4, 2018
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SC-005
SC-005 intravenous (IV) (various doses and dose regimens)
Drug: SC-005
intravenous




Primary Outcome Measures :
  1. Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Minimum 21 days ]
    DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.


Secondary Outcome Measures :
  1. QTcF Change from Baseline [ Time Frame: Up to approximately 9 weeks ]
    QT interval measurement corrected by Fridericia's formula (QTcF)

  2. Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: Up to approximately 9 weeks ]
    Area under the plasma concentration-time curve (AUC) of SC-005.

  3. Clinical benefit rate (CBR) [ Time Frame: Up to approximately 4 years ]
    CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).

  4. Maximum plasma concentration observed (Cmax) [ Time Frame: Up to approximately 9 weeks ]
    Maximum plasma concentration observed (Cmax) of SC-005

  5. Overall Survival (OS) [ Time Frame: Up to approximately 4 years ]
    OS is defined as the time from the participant's first dose date to death due to any cause.

  6. Observed Plasma Concentrations at Trough [ Time Frame: Up to approximately 9 weeks ]
    Observed plasma concentrations at trough of SC-005.

  7. Duration of Clinical Benefit (DOCB) [ Time Frame: Up to approximately 4 years ]
    DOCB is defined as the time from the participant's initial observation of clinical benefit (CR or PR or stable disease [SD]) to PD or death due to any cause, whichever occurs first.

  8. Objective Response Rate (ORR)Up to approximately 4 years [ Time Frame: Up to approximately 4 years ]
    Objective response rate is defined as the proportion of participants with complete response (CR) or partial response (PR) based on RECIST version 1.1.

  9. Time of Cmax (Tmax) [ Time Frame: Up to approximately 9 weeks ]
    Time of Cmax (Tmax) of SC-005.

  10. Progression Free Survival (PFS) [ Time Frame: Up to approximately 4 years ]
    PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause.

  11. Duration of Response (DOR) [ Time Frame: Up to approximately 4 years ]
    DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression (PD) or death due to any cause, whichever occurs first.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316794


Locations
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United States, Illinois
University of Chicago /ID# 169231
Chicago, Illinois, United States, 60637-1443
United States, Missouri
Washington University School /ID# 169177
Saint Louis, Missouri, United States, 63108
United States, New York
Memorial Sloan Kettering /ID# 201016
New York, New York, United States, 10065
United States, Ohio
Gabrail Cancer Center Research /ID# 168756
Canton, Ohio, United States, 44718
United States, Oklahoma
Oklahoma University /ID# 200937
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233
Nashville, Tennessee, United States, 37203
United States, Texas
Baylor University /ID# 169860
Houston, Texas, United States, 77030
MD Anderson Cancer Center /ID# 169232
Houston, Texas, United States, 77030
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03316794     History of Changes
Other Study ID Numbers: M16-735
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Triple Negative Breast Cancer
Cancer
Breast Cancer
Maximum tolerated dose (MTD)
Pharmacokinetics

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases