Trial Outcomes & Findings for A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation (NCT NCT02432690)

Last Updated: 2023-11-15

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks

Results posted on

2023-11-15

Participant Flow

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.

Participants who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A n=13 Participants 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.
Age, Continuous	60.6 years STANDARD_DEVIATION 9.56 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Arm A n=13 Participants 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.
Number of Patients With Adverse Events	9 participants

Adverse Events

Arm A

Serious events: 1 serious events

Other events: 9 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Arm A n=13 participants at risk 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.
Investigations Blood creatinine increased	7.7% 1/13 • 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.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • 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.
Renal and urinary disorders Urinary tract obstruction	7.7% 1/13 • 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.

Other adverse events

Other adverse events
Measure	Arm A n=13 participants at risk 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.
Gastrointestinal disorders Diarrhoea	61.5% 8/13 • 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.
Gastrointestinal disorders Abdominal pain	38.5% 5/13 • 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.
Gastrointestinal disorders Nausea	30.8% 4/13 • 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.
Gastrointestinal disorders Vomiting	30.8% 4/13 • 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.
Gastrointestinal disorders Abdominal pain upper	7.7% 1/13 • 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.
Gastrointestinal disorders Constipation	7.7% 1/13 • 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.
Gastrointestinal disorders Hypoaesthesia oral	7.7% 1/13 • 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.
General disorders Fatigue	46.2% 6/13 • 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.
General disorders Mucosal inflammation	15.4% 2/13 • 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.
Metabolism and nutrition disorders Decreased appetite	38.5% 5/13 • 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.
Blood and lymphatic system disorders Lymphopenia	23.1% 3/13 • 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.
Investigations Blood creatinine increased	15.4% 2/13 • 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.
Investigations Aspartate aminotransferase increased	7.7% 1/13 • 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.
Investigations Bacterial test positive	7.7% 1/13 • 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.
Investigations Haemoglobin decreased	7.7% 1/13 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	15.4% 2/13 • 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.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • 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.
Nervous system disorders Dizziness	7.7% 1/13 • 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.
Nervous system disorders Migraine	7.7% 1/13 • 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.
Psychiatric disorders Anxiety	7.7% 1/13 • 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.
Renal and urinary disorders Acute kidney injury	7.7% 1/13 • 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.
Renal and urinary disorders Urinary tract obstruction	7.7% 1/13 • 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.
Skin and subcutaneous tissue disorders Alopecia	7.7% 1/13 • 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.

Additional Information

Tegan Nguyen

Sumitomo Pharma Oncology

Phone: 617-674-8745

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60