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A Study of SC‑004 in Subjects With Advanced Solid Tumors

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT03138408
First received: May 1, 2017
Last updated: August 28, 2017
Last verified: August 2017
  Purpose
This is a multicenter, first-in-human study of SC-004 in participants with advanced solid cancers. This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A will involve dose escalation to define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and schedule. Part B will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A.

Condition Intervention Phase
Advanced Solid Tumor Cancers Drug: SC-004 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase 1 Study of SC‑004 in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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:
  • 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)

  • 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).

  • 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.

  • 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.

  • 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.

  • Maximum observed serum concentration (Cmax) of SC-004 [ Time Frame: Approximately 1 year ]
    Maximum observed serum concentration of SC-004

  • Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-004 [ Time Frame: Approximately 1 year ]
    Area under the plasma concentration-time curve within a dosing interval of SC-004

  • Time to Cmax (Tmax) of SC-004 [ Time Frame: Approximately 1 year ]
    Time to Cmax of SC-004

  • Observed plasma concentrations at trough (Ctrough) of SC-004 [ Time Frame: Approximately 1 year ]
    Observed plasma concentrations at trough of SC-004

  • Terminal half life (T1/2) of SC-004 [ Time Frame: Approximately 1 year ]
    Terminal half life (T1/2) of SC-004

  • 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)


Estimated Enrollment: 108
Actual Study Start Date: June 20, 2017
Estimated Study Completion Date: June 15, 2021
Estimated Primary Completion Date: August 31, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC-004
SC-004 intravenous (IV) (various doses and dose regimens)
Drug: SC-004
Intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    • High-grade serous ovarian epithelial cancer, including epithelial ovarian cancer, fallopian tubal cancer or peritoneal cancer of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least 1 platinum-based chemotherapeutic regimen
    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03138408

Contacts
Contact: AbbVie_Call Center 847-283-8955 AbbVieClinicalTrials@AbbVie.com

Locations
United States, Ohio
OSU Wexner Medical Center /ID# 164089 Not yet recruiting
Columbus, Ohio, United States, 43210
United States, Oklahoma
Stephenson Cancer Center /ID# 164090 Recruiting
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Tennessee Oncology, PLLC /ID# 164088 Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Edward Kavalerchik, MD AbbVie_Stemcentrx
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03138408     History of Changes
Other Study ID Numbers: M16-553
Study First Received: May 1, 2017
Last Updated: August 28, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AbbVie:
Ovarian cancer
SC-004
Solid tumor cancers
Maximum tolerated dose (MTD)
Endometrial cancer
Cancer

ClinicalTrials.gov processed this record on September 21, 2017