Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

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.

BBI503

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.

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

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

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).

The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation

The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation

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).

Defined as the time from enrollment to death due to any cause.

Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events

Sumitomo Pharma America, Inc.

Participants who were enrolled into the study received amcasertib (BBI503), administered orally, once daily. Dosing began at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events was allowed according to following schedule: Full dose: 200 mg daily; Modification Level-1: 100 mg daily; Modification Level-2: 50 mg daily.

Arm A

Age, Continuous

Sex: Female, Male

Not Hispanic or Latino

Hispanic or Latino

Not Reported

Unknown

Missing

Race/Ethnicity, Customized

United States

Region of Enrollment

Tegan Nguyen

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the DCR was not performed since data were not collected.

Disease Control Rate (DCR)

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the PFS was not performed since data were not collected.

Progression Free Survival (PFS)

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the PFS-6 was not performed since data were not collected.

Progression Free Survival (PFS)-6

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the ORR was not performed since data were not collected.

Objective Response Rate (ORR)

Due to a lack of efficacy in the solid tumor indications that were evaluated in early-stage trials of this compound, the entirety of the amcasertib development was discontinued by the sponsor. Analysis of the OS at 6 months was not performed since data were not collected.

Spots Global Cancer Trial Database for A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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