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

Phase 1

Terminated

• Conditions: Cancer
• Interventions: Drug: SC-004; Drug: ABBV-181

• Registration Number: NCT03138408
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-03
• Study Start: 2017-06-14
• Status Verified: 2019-05
• Primary Completion: 2019-05-02
• Study Completion: 2019-05-02
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

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.

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Exclusion Criteria

• Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SC-004	SC-004	-
SC-004 and ABBV-181	SC-004	-
SC-004 and ABBV-181	ABBV-181	-

Primary Outcome Measures

Name	Time	Method
Number of participants with dose-limiting toxicities (DLT)	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Approximately 2 years	ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).
Observed plasma concentrations at trough (Ctrough)	Approximately 1 year	Observed plasma concentrations at trough.
Duration of Response (DOR)	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)	Approximately 1 year	Area under the plasma concentration-time curve within a dosing interval.
QTcF Change from Baseline	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)	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.
Overall Survival (OS)	Approximately 2 years	OS is defined as the time from the subject's first dose date to death due to any cause.
Terminal half life (T1/2)	Approximately 1 year	Terminal half life (T1/2).
Maximum observed serum concentration (Cmax)	Approximately 1 year	Maximum observed serum concentration.
Time to Cmax (Tmax)	Approximately 1 year	Time to Cmax.
Clinical Benefit Rate (CBR)	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)	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.

Trial Locations

Locations (12)

Highlands Oncology Group /ID# 209165; 🇺🇸 Fayetteville, Arkansas, United States

City of Hope /ID# 202493; 🇺🇸 Duarte, California, United States

The Ohio State University - Columbus /ID# 164089; 🇺🇸 Columbus, Ohio, United States

Tennessee Oncology-Nashville Centennial /ID# 164088; 🇺🇸 Nashville, Tennessee, United States

MD Anderson Cancer Center /ID# 200048; 🇺🇸 Houston, Texas, United States

Henry Ford Health System /ID# 202480; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic - Rochester /ID# 200732; 🇺🇸 Rochester, Minnesota, United States

University of Alabama /ID# 202249; 🇺🇸 Birmingham, Alabama, United States

University of Chicago /ID# 200735; 🇺🇸 Chicago, Illinois, United States

Washington University School /ID# 164091; 🇺🇸 Saint Louis, Missouri, United States

Huntsman Cancer Institute /ID# 209164; 🇺🇸 Salt Lake City, Utah, United States

Univ Oklahoma HSC /ID# 164090; 🇺🇸 Oklahoma City, Oklahoma, United States