Back to resultsSC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
Primary Purpose
Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SC-004
ABBV-181
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Ovarian cancer, Endometrial cancer, SC-004, Maximum tolerated dose (MTD), ABBV-181
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:
Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy.
- Note, the line of therapy limit does not apply to the biopsy substudy cohorts.
- Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Adequate hematologic, hepatic, and renal function.
Exclusion Criteria:
- Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Sites / Locations
- University of Alabama /ID# 202249
- Highlands Oncology Group /ID# 209165
- City of Hope /ID# 202493
- University of Chicago /ID# 200735
- Henry Ford Health System /ID# 202480
- Mayo Clinic - Rochester /ID# 200732
- Washington University School /ID# 164091
- The Ohio State University - Columbus /ID# 164089
- Univ Oklahoma HSC /ID# 164090
- Tennessee Oncology-Nashville Centennial /ID# 164088
- MD Anderson Cancer Center /ID# 200048
- Huntsman Cancer Institute /ID# 209164
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SC-004
SC-004 and ABBV-181
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with dose-limiting toxicities (DLT)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Secondary Outcome Measures
Observed plasma concentrations at trough (Ctrough)
Observed plasma concentrations at trough.
Overall Survival (OS)
OS is defined as the time from the subject's first dose date to death due to any cause.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).
Terminal half life (T1/2)
Terminal half life (T1/2).
Maximum observed serum concentration (Cmax)
Maximum observed serum concentration.
Time to Cmax (Tmax)
Time to Cmax.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).
Progression Free Survival (PFS)
PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression or death due to any cause, whichever occurs first. Under the situation that neither event occurs, the PFS time will be censored at the date of last tumor assessment. Subjects lacking an evaluation of tumor response after their first dose of study treatment will have their event time censored at Day 1.
Duration of Response (DOR)
DOR is defined as the time from the subject's initial objective response (CR or PR) to study drug therapy to disease progression or death due to any cause, whichever occurs first. If the dates of disease progression or death are not available, the DOR will be censored at the date of last valid tumor assessment.
Area under the plasma concentration-time curve within a dosing interval (AUC)
Area under the plasma concentration-time curve within a dosing interval.
QTcF Change from Baseline
QT interval measurement corrected by Fridericia's formula (QTcF).
Duration of Clinical Benefit (DOCB)
DOCB is defined as the time from a subject's objective response (CR or PR) or stable disease (SD) to study drug therapy to disease progression or death due to any cause whichever occurs first.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03138408
Brief Title
SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
Official Title
An Open Label, Phase 1 Study of SC-004 as Monotherapy and in Combination With ABBV-181 in Subjects With Epithelial Ovarian, Including Fallopian Tube and Primary Peritoneal and Endometrial Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Strategic considerations
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 2, 2019 (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 two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Ovarian cancer, Endometrial cancer, SC-004, Maximum tolerated dose (MTD), ABBV-181
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SC-004
Arm Type
Experimental
Arm Title
SC-004 and ABBV-181
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SC-004
Intervention Description
Intravenous
Intervention Type
Drug
Intervention Name(s)
ABBV-181
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicities (DLT)
Description
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame
Minimum first cycle of dosing (21-day cycles)
Secondary Outcome Measure Information:
Title
Observed plasma concentrations at trough (Ctrough)
Description
Observed plasma concentrations at trough.
Time Frame
Approximately 1 year
Title
Overall Survival (OS)
Description
OS is defined as the time from the subject's first dose date to death due to any cause.
Time Frame
Approximately 2 years
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).
Time Frame
Approximately 2 years
Title
Terminal half life (T1/2)
Description
Terminal half life (T1/2).
Time Frame
Approximately 1 year
Title
Maximum observed serum concentration (Cmax)
Description
Maximum observed serum concentration.
Time Frame
Approximately 1 year
Title
Time to Cmax (Tmax)
Description
Time to Cmax.
Time Frame
Approximately 1 year
Title
Clinical Benefit Rate (CBR)
Description
CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).
Time Frame
Approximately 2 years
Title
Progression Free Survival (PFS)
Description
PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression or death due to any cause, whichever occurs first. Under the situation that neither event occurs, the PFS time will be censored at the date of last tumor assessment. Subjects lacking an evaluation of tumor response after their first dose of study treatment will have their event time censored at Day 1.
Time Frame
Approximately 2 years
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the subject's initial objective response (CR or PR) to study drug therapy to disease progression or death due to any cause, whichever occurs first. If the dates of disease progression or death are not available, the DOR will be censored at the date of last valid tumor assessment.
Time Frame
Approximately 2 years
Title
Area under the plasma concentration-time curve within a dosing interval (AUC)
Description
Area under the plasma concentration-time curve within a dosing interval.
Time Frame
Approximately 1 year
Title
QTcF Change from Baseline
Description
QT interval measurement corrected by Fridericia's formula (QTcF).
Time Frame
Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
Title
Duration of Clinical Benefit (DOCB)
Description
DOCB is defined as the time from a subject's objective response (CR or PR) or stable disease (SD) to study drug therapy to disease progression or death due to any cause whichever occurs first.
Time Frame
Approximately 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:
Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy.
Note, the line of therapy limit does not apply to the biopsy substudy cohorts.
Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
Eastern Cooperative Oncology Group (ECOG) 0-1.
Adequate hematologic, hepatic, and renal function.
Exclusion Criteria:
Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
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 Alabama /ID# 202249
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Highlands Oncology Group /ID# 209165
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703-4005
Country
United States
Facility Name
City of Hope /ID# 202493
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of Chicago /ID# 200735
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Henry Ford Health System /ID# 202480
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 200732
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Washington University School /ID# 164091
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
The Ohio State University - Columbus /ID# 164089
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Univ Oklahoma HSC /ID# 164090
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 164088
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
MD Anderson Cancer Center /ID# 200048
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute /ID# 209164
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
We'll reach out to this number within 24 hrs