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A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation

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ClinicalTrials.gov Identifier: NCT02432690
Recruitment Status : Active, not recruiting
First Posted : May 4, 2015
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc

Brief Summary:
This is an open label, single-arm, phase II study. The study population is adult patients with asymptomatic recurrent ovarian cancer who have an elevation in their CA-125 level.

Condition or disease Intervention/treatment Phase
Cancer Ovarian Cancer Drug: BBI503 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
Study Start Date : June 2015
Estimated Primary Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Arm A Drug: BBI503
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.
Other Names:
  • Amcasertib
  • BB503
  • BBI-503




Primary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 8 weeks ]
    Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease).


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 24 months ]
    Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.

  2. Progression Free Survival (PFS)-6 [ Time Frame: 6 months ]
    Defined as the proportion of patients with progression free survival (PFS) i.e. absence of documented objective progression or death at 6 months after enrollment

  3. Objective Response Rate (ORR) [ Time Frame: 8 weeks ]
    Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease).

  4. Overall Survival (OS) [ Time Frame: 24 months ]
    Defined as the time from enrollment to death due to any cause.

  5. Number of Patients with Adverse Events [ Time Frame: 24 months ]
    The incidence of adverse events will be summarized by type of adverse event and severity.



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

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 ClinicalTrials.gov identifier (NCT number): NCT02432690


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Boston Biomedical, Inc

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT02432690     History of Changes
Other Study ID Numbers: BBI503-205GYN-M
BBI503-205GOV-M ( Other Identifier: Boston Biomedical, Inc. )
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Keywords provided by Boston Biomedical, Inc:
Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders