Clinical trial NCT03138408: SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Keywords: Ovarian cancer
Endometrial cancer
SC-004
Maximum tolerated dose (MTD)
ABBV-181
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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:

  * 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.

Primary outcomes:
measure: Number of participants with dose-limiting toxicities (DLT)
timeFrame: Minimum first cycle of dosing (21-day cycles)
Secondary outcomes:
measure: Observed plasma concentrations at trough (Ctrough)
timeFrame: Approximately 1 year
measure: Overall Survival (OS)
timeFrame: Approximately 2 years
measure: Objective Response Rate (ORR)
timeFrame: Approximately 2 years
measure: Terminal half life (T1/2)
timeFrame: Approximately 1 year
measure: Maximum observed serum concentration (Cmax)
timeFrame: Approximately 1 year
measure: Time to Cmax (Tmax)
timeFrame: Approximately 1 year
measure: Clinical Benefit Rate (CBR)
timeFrame: Approximately 2 years
measure: Progression Free Survival (PFS)
timeFrame: Approximately 2 years
measure: Duration of Response (DOR)
timeFrame: Approximately 2 years
measure: Area under the plasma concentration-time curve within a dosing interval (AUC)
timeFrame: Approximately 1 year
measure: QTcF Change from Baseline
timeFrame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
measure: Duration of Clinical Benefit (DOCB)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama /ID# 202249
state: Alabama
city: Fayetteville
country: United States
facility: Highlands Oncology Group /ID# 209165
state: Arkansas
city: Duarte
country: United States
facility: City of Hope /ID# 202493
state: California
city: Chicago
country: United States
facility: University of Chicago /ID# 200735
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 202480
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 200732
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School /ID# 164091
state: Missouri
city: Columbus
country: United States
facility: The Ohio State University - Columbus /ID# 164089
state: Ohio
city: Oklahoma City
country: United States
facility: Univ Oklahoma HSC /ID# 164090
state: Oklahoma
city: Nashville
country: United States
facility: Tennessee Oncology-Nashville Centennial /ID# 164088
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center /ID# 200048
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute /ID# 209164
state: Utah
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: