A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
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| ClinicalTrials.gov Identifier: NCT03316794 |
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Recruitment Status :
Terminated
(Strategic considerations)
First Posted : October 20, 2017
Last Update Posted : December 17, 2018
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
- Study Details
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Allocation: | N/A |
| 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 Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: SC-005
SC-005 intravenous (IV) (various doses and dose regimens)
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Drug: SC-005
intravenous |
Primary Outcome Measures :
- 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 :
- QTcF Change from Baseline [ Time Frame: Up to approximately 9 weeks ]QT interval measurement corrected by Fridericia's formula (QTcF)
- 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.
- 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).
- Maximum plasma concentration observed (Cmax) [ Time Frame: Up to approximately 9 weeks ]Maximum plasma concentration observed (Cmax) of SC-005
- 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.
- Observed Plasma Concentrations at Trough [ Time Frame: Up to approximately 9 weeks ]Observed plasma concentrations at trough of SC-005.
- 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.
- 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.
- Time of Cmax (Tmax) [ Time Frame: Up to approximately 9 weeks ]Time of Cmax (Tmax) of SC-005.
- 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.
- 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:
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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
| 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
| Study Director: | AbbVie Inc. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT03316794 |
| 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 |
| 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:
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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 |