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| ID | Type | Description | Link |
|---|---|---|---|
| BBI503-205GOV-M | Other Identifier | Sumitomo Pharma Oncology, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBI503 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | 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). | From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation | 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 |
| Progression Free Survival (PFS)-6 |
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Key inclusion criteria:
Histological or cytological confirmation of epithelial ovarian, primary peritoneal, or fallopian cancer from any previous time point.
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)
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
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
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0
Key exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
Participants who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.
A total of 13 participants who met all inclusion criteria and no exclusion criteria were enrolled and received treatment at 1 clinical site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease Control Rate (DCR) | 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). | 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. | Posted | From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks |
|
Serious and Other Adverse Events were assessed from the date of first treatment through 30 days of the last administration of study drug, an average of 4 months. All-Cause Mortality was assessed from the date of first treatment until death, up to 18 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatinine increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tegan Nguyen | Sumitomo Pharma Oncology | 617-674-8745 | tegan.nguyen@oncology.sumitomo-pharma.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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|
|
The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation |
| 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 |
| Objective Response Rate (ORR) | 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). | From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months |
| Overall Survival (OS) at 6 Months | Defined as the time from enrollment to death due to any cause. | 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months |
| Number of Patients With Adverse Events | Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Progression Free Survival (PFS) | The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation | 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. | Posted | 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 |
|
|
| Secondary | Progression Free Survival (PFS)-6 | The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation | 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. | Posted | 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 |
|
|
| Secondary | Objective Response Rate (ORR) | 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). | 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. | Posted | From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months |
|
|
| Secondary | Overall Survival (OS) at 6 Months | Defined as the time from enrollment to death due to any cause. | 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. | Posted | 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months |
|
|
| Secondary | Number of Patients With Adverse Events | Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events | Posted | Number | participants | 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. |
|
|
|
| 3 |
| 13 |
| 1 |
| 13 |
| 9 |
| 13 |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA (19.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Bacterial test positive | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |