Back to resultsA Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SC-005
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Triple Negative Breast Cancer, Cancer, Breast Cancer, Maximum tolerated dose (MTD), Pharmacokinetics
Eligibility 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.
Sites / Locations
- University of Chicago /ID# 169231
- Washington University School /ID# 169177
- Memorial Sloan Kettering /ID# 201016
- Gabrail Cancer Center Research /ID# 168756
- Oklahoma University /ID# 200937
- Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233
- Baylor University /ID# 169860
- MD Anderson Cancer Center /ID# 169232
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SC-005
Arm Description
SC-005 intravenous (IV) (various doses and dose regimens)
Outcomes
Primary Outcome Measures
Number of Participants with Dose-limiting Toxicities (DLTs)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Secondary Outcome Measures
QTcF Change from Baseline
QT interval measurement corrected by Fridericia's formula (QTcF)
Area Under the Plasma Concentration-time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of SC-005.
Clinical benefit rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).
Maximum plasma concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of SC-005
Overall Survival (OS)
OS is defined as the time from the participant's first dose date to death due to any cause.
Observed Plasma Concentrations at Trough
Observed plasma concentrations at trough of SC-005.
Duration of Clinical Benefit (DOCB)
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.
Objective Response Rate (ORR)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.
Time of Cmax (Tmax)
Time of Cmax (Tmax) of SC-005.
Progression Free Survival (PFS)
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.
Duration of Response (DOR)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03316794
Brief Title
A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Official Title
An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Triple Negative Breast Cancer, Cancer, Breast Cancer, Maximum tolerated dose (MTD), Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SC-005
Arm Type
Experimental
Arm Description
SC-005 intravenous (IV) (various doses and dose regimens)
Intervention Type
Drug
Intervention Name(s)
SC-005
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
Number of Participants with Dose-limiting Toxicities (DLTs)
Description
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame
Minimum 21 days
Secondary Outcome Measure Information:
Title
QTcF Change from Baseline
Description
QT interval measurement corrected by Fridericia's formula (QTcF)
Time Frame
Up to approximately 9 weeks
Title
Area Under the Plasma Concentration-time Curve (AUC)
Description
Area under the plasma concentration-time curve (AUC) of SC-005.
Time Frame
Up to approximately 9 weeks
Title
Clinical benefit rate (CBR)
Description
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).
Time Frame
Up to approximately 4 years
Title
Maximum plasma concentration observed (Cmax)
Description
Maximum plasma concentration observed (Cmax) of SC-005
Time Frame
Up to approximately 9 weeks
Title
Overall Survival (OS)
Description
OS is defined as the time from the participant's first dose date to death due to any cause.
Time Frame
Up to approximately 4 years
Title
Observed Plasma Concentrations at Trough
Description
Observed plasma concentrations at trough of SC-005.
Time Frame
Up to approximately 9 weeks
Title
Duration of Clinical Benefit (DOCB)
Description
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.
Time Frame
Up to approximately 4 years
Title
Objective Response Rate (ORR)Up to approximately 4 years
Description
Objective response rate is defined as the proportion of participants with complete response (CR) or partial response (PR) based on RECIST version 1.1.
Time Frame
Up to approximately 4 years
Title
Time of Cmax (Tmax)
Description
Time of Cmax (Tmax) of SC-005.
Time Frame
Up to approximately 9 weeks
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 4 years
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to approximately 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Chicago /ID# 169231
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Washington University School /ID# 169177
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Memorial Sloan Kettering /ID# 201016
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Gabrail Cancer Center Research /ID# 168756
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Oklahoma University /ID# 200937
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor University /ID# 169860
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center /ID# 169232
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
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