SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers

Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03138408
• Other study ID #: M16-553
• Status: Terminated
• Phase: Phase 1
• Start date: June 14, 2017
• Est. completion date: May 2, 2019

Study information

• Verified date: May 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Endometrial Neoplasms

Intervention

Drug:
• SC-004
Intravenous
• ABBV-181
Intravenous

Locations

Country	Name	City	State
United States	University of Alabama /ID# 202249	Birmingham	Alabama
United States	University of Chicago /ID# 200735	Chicago	Illinois
United States	The Ohio State University - Columbus /ID# 164089	Columbus	Ohio
United States	Henry Ford Health System /ID# 202480	Detroit	Michigan
United States	City of Hope /ID# 202493	Duarte	California
United States	Highlands Oncology Group /ID# 209165	Fayetteville	Arkansas
United States	MD Anderson Cancer Center /ID# 200048	Houston	Texas
United States	Tennessee Oncology-Nashville Centennial /ID# 164088	Nashville	Tennessee
United States	Univ Oklahoma HSC /ID# 164090	Oklahoma City	Oklahoma
United States	Mayo Clinic - Rochester /ID# 200732	Rochester	Minnesota
United States	Washington University School /ID# 164091	Saint Louis	Missouri
United States	Huntsman Cancer Institute /ID# 209164	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Minimum first cycle of dosing (21-day cycles)
Secondary	Observed plasma concentrations at trough (Ctrough)	Observed plasma concentrations at trough.	Approximately 1 year
Secondary	Overall Survival (OS)	OS is defined as the time from the subject's first dose date to death due to any cause.	Approximately 2 years
Secondary	Objective Response Rate (ORR)	ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).	Approximately 2 years
Secondary	Terminal half life (T1/2)	Terminal half life (T1/2).	Approximately 1 year
Secondary	Maximum observed serum concentration (Cmax)	Maximum observed serum concentration.	Approximately 1 year
Secondary	Time to Cmax (Tmax)	Time to Cmax.	Approximately 1 year
Secondary	Clinical Benefit Rate (CBR)	CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).	Approximately 2 years
Secondary	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.	Approximately 2 years
Secondary	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.	Approximately 2 years
Secondary	Area under the plasma concentration-time curve within a dosing interval (AUC)	Area under the plasma concentration-time curve within a dosing interval.	Approximately 1 year
Secondary	QTcF Change from Baseline	QT interval measurement corrected by Fridericia's formula (QTcF).	Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
Secondary	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.	Approximately 2 years