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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. Identifier: NCT03138408
Recruitment Status : Active, not recruiting
First Posted : May 3, 2017
Last Update Posted : January 29, 2019
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: SC-004 Drug: ABBV-181 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SC-004 Drug: SC-004

Experimental: SC-004 and ABBV-181 Drug: SC-004

Drug: ABBV-181

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Observed plasma concentrations at trough (Ctrough) [ Time Frame: Approximately 1 year ]
    Observed plasma concentrations at trough.

  2. 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.

  3. 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).

  4. Terminal half life (T1/2) [ Time Frame: Approximately 1 year ]
    Terminal half life (T1/2).

  5. Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 1 year ]
    Maximum observed serum concentration.

  6. Time to Cmax (Tmax) [ Time Frame: Approximately 1 year ]
    Time to Cmax.

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03138408

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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
Sponsors and Collaborators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie Identifier: NCT03138408     History of Changes
Other Study ID Numbers: M16-553
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by AbbVie:
Ovarian cancer
Endometrial cancer
Maximum tolerated dose (MTD)

Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female