SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03138408|
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: SC-004 Drug: ABBV-181||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 14, 2017|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||June 15, 2021|
|Experimental: SC-004 and ABBV-181||
- Number of participants with dose-limiting toxicities (DLT) [ Time Frame: Minimum first cycle of dosing (21-day cycles) ]DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
- Observed plasma concentrations at trough (Ctrough) [ Time Frame: Approximately 1 year ]Observed plasma concentrations at trough.
- Overall Survival (OS) [ Time Frame: Approximately 2 years ]OS is defined as the time from the subject's first dose date to death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: Approximately 2 years ]ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).
- Terminal half life (T1/2) [ Time Frame: Approximately 1 year ]Terminal half life (T1/2).
- Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 1 year ]Maximum observed serum concentration.
- Time to Cmax (Tmax) [ Time Frame: Approximately 1 year ]Time to Cmax.
- Clinical Benefit Rate (CBR) [ Time Frame: Approximately 2 years ]CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).
- Progression Free Survival (PFS) [ Time Frame: Approximately 2 years ]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) [ Time Frame: Approximately 2 years ]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) [ Time Frame: Approximately 1 year ]Area under the plasma concentration-time curve within a dosing interval.
- QTcF Change from Baseline [ Time Frame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles) ]QT interval measurement corrected by Fridericia's formula (QTcF).
- Duration of Clinical Benefit (DOCB) [ Time Frame: Approximately 2 years ]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.
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): NCT03138408
|United States, Alabama|
|University of Alabama /ID# 202249|
|Birmingham, Alabama, United States, 35294|
|United States, Arkansas|
|Highlands Oncology Group /ID# 209165|
|Fayetteville, Arkansas, United States, 72703-4005|
|United States, California|
|City of Hope /ID# 202493|
|Duarte, California, United States, 91010|
|United States, Illinois|
|University of Chicago /ID# 200735|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|Henry Ford Health System /ID# 202480|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|Mayo Clinic - Rochester /ID# 200732|
|Rochester, Minnesota, United States, 55905-0001|
|United States, Missouri|
|Washington University School /ID# 164091|
|Saint Louis, Missouri, United States, 63108|
|United States, Ohio|
|The Ohio State University - Columbus /ID# 164089|
|Columbus, Ohio, United States, 43210|
|United States, Oklahoma|
|Univ Oklahoma HSC /ID# 164090|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Tennessee|
|Tennessee Oncology-Sarah Cannon Research Institute /ID# 164088|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|MD Anderson Cancer Center /ID# 200048|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Huntsman Cancer Institute /ID# 209164|
|Salt Lake City, Utah, United States, 84112-5500|
|Study Director:||AbbVie Inc.||AbbVie|