A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Condition: Cancer; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: BBI503
Intervention description: BBI503 will be administered orally, once daily. Dosing will begin at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events is allowed according to the schedule below; Full dose: 200 mg daily, Modification Level-1: 100 mg daily, Modification Level-2: 50 mg daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms

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.