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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432690
Recruitment Status : Terminated
First Posted : May 4, 2015
Results First Posted : August 29, 2022
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
Sumitomo Pharma Oncology, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
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
Actual Primary Completion Date : January 2, 2017
Actual Study Completion Date : January 2, 2017

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: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 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). DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 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 ]
    The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation

  2. Progression Free Survival (PFS)-6 [ Time Frame: 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 ]
    The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation

  3. Objective Response Rate (ORR) [ Time Frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months ]
    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) at 6 Months [ Time Frame: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months ]
    Defined as the time from enrollment to death due to any cause.

  5. Number of Patients With Adverse Events [ Time Frame: 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. ]
    Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events



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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
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Sumitomo Pharma Oncology, Inc.
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Responsible Party: Sumitomo Pharma Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02432690    
Other Study ID Numbers: BBI503-205GYN-M
BBI503-205GOV-M ( Other Identifier: Sumitomo Pharma Oncology, Inc. )
First Posted: May 4, 2015    Key Record Dates
Results First Posted: August 29, 2022
Last Update Posted: August 29, 2022
Last Verified: August 2022
Keywords provided by Sumitomo Pharma Oncology, Inc.:
Neoplasms
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type