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

NCT ID: NCT03138408

Last Updated: 2019-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-14

Study Completion Date

2019-05-02

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SC-004

Group Type EXPERIMENTAL

SC-004

Intervention Type DRUG

Intravenous

SC-004 and ABBV-181

Group Type EXPERIMENTAL

SC-004

Intervention Type DRUG

Intravenous

ABBV-181

Intervention Type DRUG

Intravenous

Interventions

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SC-004

Intravenous

Intervention Type DRUG

ABBV-181

Intravenous

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of Alabama /ID# 202249

Birmingham, Alabama, United States

Site Status

Highlands Oncology Group /ID# 209165

Fayetteville, Arkansas, United States

Site Status

City of Hope /ID# 202493

Duarte, California, United States

Site Status

University of Chicago /ID# 200735

Chicago, Illinois, United States

Site Status

Henry Ford Health System /ID# 202480

Detroit, Michigan, United States

Site Status

Mayo Clinic - Rochester /ID# 200732

Rochester, Minnesota, United States

Site Status

Washington University School /ID# 164091

St Louis, Missouri, United States

Site Status

The Ohio State University - Columbus /ID# 164089

Columbus, Ohio, United States

Site Status

Univ Oklahoma HSC /ID# 164090

Oklahoma City, Oklahoma, United States

Site Status

Tennessee Oncology-Nashville Centennial /ID# 164088

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center /ID# 200048

Houston, Texas, United States

Site Status

Huntsman Cancer Institute /ID# 209164

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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M16-553

Identifier Type: -

Identifier Source: org_study_id

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