Clinical trial NCT02432690: A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Official title: A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Ovarian Cancer
Keywords: Neoplasms
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label, single-arm, Phase II study in which amcasertib (BBI503) was administered to adult, asymptomatic patients with recurrent ovarian cancer who had elevated CA-125.


Eligibility criteria: Key inclusion criteria:

1. Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point.
2. Recurrent or relapsed after completion of initial therapy of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point (includes completion of surgery with or without postoperative chemotherapy, including maintenance chemotherapy)
3. Elevation of CA-125 according to the following definitions:

   * Patients with an elevated CA-125 before chemotherapy and normalization of CA-125 with/after chemotherapy must show evidence of CA-125 greater than or equal to 2 times the upper limit of normal (ULN) on 2 occasions at least 1 week apart
   * Patients with an elevated CA-125 before cancer chemotherapy, which never normalizes, must show evidence of CA-125 greater than or equal to 2 times the nadir value on 2 occasions at least 1 week apart
   * Patients with CA-125 in the normal range before cancer chemotherapy must show evidence of CA-125 greater than or equal to 2 times the ULN on 2 occasions at least 1 week apart

     * For patients who have received subsequent treatment for recurrent cancer, "chemotherapy" in the above criteria refers to the most recent round of chemotherapy.
4. Patients with a history of ovarian cancer who are asymptomatic and who do not have documented previous CA-125 levels may enroll if the CA-125 is greater than three times the ULN on two occasions, at least one week apart
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0

Key exclusion criteria:

1. Symptoms (other than ≤ grade 1 fatigue, anxiety, depression, or other psychological symptoms) that, in the opinion of the treating oncologist, are a direct result of cancer recurrence. (Examples of symptoms that would preclude enrollment include unintentional weight loss, ≥ grade 2 fatigue, and new abdominal pain unrelated to operative procedures for the ovarian malignancy.)
2. Receiving any other investigational agent that would be considered a treatment for the primary neoplasm. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents ≤14 days of first dose of study drug
3. Major surgery ≤28 days before start of treatment
4. History of another primary malignancy with an associated disease-free interval of less than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix.

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 18 months
measure: Progression Free Survival (PFS)-6
timeFrame: The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months
measure: Objective Response Rate (ORR)
timeFrame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months
measure: Overall Survival (OS) at 6 Months
timeFrame: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months
measure: Number of Patients With Adverse Events
timeFrame: The time from the date of first treatment, while the patient is taking amcasertib, and for 30 days after stopping therapy, an average of 4 months.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References: