Trial Outcomes & Findings for Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer (NCT NCT05276973)

NCT ID: NCT05276973

Last Updated: 2025-12-19

Results Overview

The incidence of DLTs was assessed based on the number of participants who experienced at least one dose-limiting toxicity (DLT) during the Dose Escalation phase, which was used to estimate the maximum tolerated dose (MTD). A DLT was defined as any protocol-specified adverse event that was possibly, probably, or definitely related to study drug combination and occurred during the first cycle of neoadjuvant chemotherapy, unless the event was clearly unrelated to the study therapy. Adverse events were assessed and graded according to NCI CTCAE v5.0.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1
• Target enrollment: 25 participants
• Primary outcome timeframe: First cycle of 21 days
• Results posted on: 2025-12-19

Participant Flow

NRG-GY027 opened to accrual on June 27, 2022, and closed to accrual on December 20, 2024 with a total of 25 participants enrolled.

Participant milestones

Measure	Dose Level 1 (DL1) Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	Dose Level 1 (DL1) Dose Expansion-only Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	Dose Level 2 (DL2) Dose Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Overall Study STARTED	7	13	5
Overall Study COMPLETED	6	12	5
Overall Study NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	Dose Level 1 (DL1) Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	Dose Level 1 (DL1) Dose Expansion-only Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	Dose Level 2 (DL2) Dose Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Overall Study Treated and DLT unevaluable	1	1	0

Baseline Characteristics

Testing the Addition of Ipatasertib to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) for Stage III or IV Epithelial Ovarian Cancer

Baseline characteristics by cohort

Measure	DL1 Escalation Cohort n=7 Participants Participants who were enrolled in the dose escalation phase and received any amount of the assigned DL1 therapy.	DL1 Dose Expansion-only Cohort n=13 Participants Participants who were enrolled in the dose expansion cohort phase only and received any amount of the assigned DL1 therapy.	DL2 Dose Escalation Cohort n=5 Participants Participants who were enrolled in the dose escalation phase and received any amount of the assigned DL2 therapy.	Total n=25 Participants Total of all reporting groups
Age, Continuous	63 years n=8 Participants	66 years n=6 Participants	69 years n=6 Participants	66 years n=9 Participants
Age, Customized 40-49	1 Participants n=8 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=9 Participants
Age, Customized 50-59	2 Participants n=8 Participants	3 Participants n=6 Participants	0 Participants n=6 Participants	5 Participants n=9 Participants
Age, Customized 60-69	2 Participants n=8 Participants	5 Participants n=6 Participants	3 Participants n=6 Participants	10 Participants n=9 Participants
Age, Customized 70-79	2 Participants n=8 Participants	3 Participants n=6 Participants	2 Participants n=6 Participants	7 Participants n=9 Participants
Age, Customized 80-89	0 Participants n=8 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants
Sex: Female, Male Female	7 Participants n=8 Participants	13 Participants n=6 Participants	5 Participants n=6 Participants	25 Participants n=9 Participants
Sex: Female, Male Male	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=8 Participants	11 Participants n=6 Participants	4 Participants n=6 Participants	21 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=8 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	1 Participants n=8 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	3 Participants n=9 Participants
Race (NIH/OMB) White	6 Participants n=8 Participants	8 Participants n=6 Participants	3 Participants n=6 Participants	17 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	4 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=9 Participants

PRIMARY outcome

Timeframe: First cycle of 21 days

Population: Participants who received the assigned DL1 protocol therapy or DL2 protocol therapy and were evaluable for DLTs during dose escalation phase.

The incidence of DLTs was assessed based on the number of participants who experienced at least one dose-limiting toxicity (DLT) during the Dose Escalation phase, which was used to estimate the maximum tolerated dose (MTD). A DLT was defined as any protocol-specified adverse event that was possibly, probably, or definitely related to study drug combination and occurred during the first cycle of neoadjuvant chemotherapy, unless the event was clearly unrelated to the study therapy. Adverse events were assessed and graded according to NCI CTCAE v5.0.

Outcome measures

Measure	DL1 Dose Escalation Cohort n=6 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=5 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Incidence of Dose Limiting Toxicities (DLTs) During Dose Escalation Phase	1 Participants	2 Participants	—

PRIMARY outcome

Timeframe: First cycle of 21 days

Population: Participants who were treated at the identified MTD level (DL1) and evaluable for DLTs. This population consisted of the 6 DLT-evaluable participants from Dose Escalation Phase and additional 12 DLT-evaluable participants from Dose Expansion Phase.

The incidence of DLTs was assessed based on the number of participants who experienced at least one DLT during the Dose Expansion phase. This assessment was used to evaluate the feasibility of the treatment regimen at the estimated MTD, specially dose level 1. A DLT was defined as any protocol-specified adverse effect that was possibly, probably, or definitely related to study drug combination and occurred during the first cycle of neoadjuvant chemotherapy, unless the event was clearly unrelated to study therapy. Adverse events were assessed and graded according to NCI CTCAE v.5.0.

Outcome measures

Measure	DL1 Dose Escalation Cohort n=18 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Incidence of Dose-limiting Toxicities (DLTs) During Dose Expansion Phase	2 Participants	—	—

PRIMARY outcome

Timeframe: During treatment period and up to 90 days after the last dose of ipatasertib. The median duration of study treatment was 68 days with a range from 1 day to 90 days.

Population: Participants who received any amount of protocol therapy.

The incidence of grade 3 or higher AEs was assessed based on the number of participants who experienced at least one grade 3 or higher adverse event. Adverse events were graded and categorized according to NCI CTCAE v5.0.

Outcome measures

Measure	DL1 Dose Escalation Cohort n=7 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=13 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=5 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Incidence of Grade 3 or Higher Adverse Events (AEs)	2 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: At 3 weeks (+/- 7 days) post Cycle 3 of the study treatment and prior to IDS.

Population: Participants who received any amount of assigned protocol therapy.

Tumor response was assessed by RECIST 1.1 at 3 weeks (+/- 7 days) post Cycle 3 of the study treatment and prior to interval debulking surgery (IDS), and it could be repeated any other time if clinically indicated based on symptoms or physical signs suggestive of new or progressive disease.

Outcome measures

Measure	DL1 Dose Escalation Cohort n=7 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=13 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=5 Participants Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Tumor Response Non-complete response/non-progressive disease	2 Participants	3 Participants	0 Participants
Tumor Response Progressive disease	0 Participants	1 Participants	0 Participants
Tumor Response Not evaluable	1 Participants	1 Participants	1 Participants
Tumor Response Complete response	0 Participants	1 Participants	0 Participants
Tumor Response Partial response	3 Participants	5 Participants	3 Participants
Tumor Response Stable disease	1 Participants	2 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 90 days

Will be summarized by collection time point and dose level. Wilcoxon signed rank test will be used to explore the change of pPRAS40 expression in the pre-treatment versus on-treatment tumor in the patients who have been treated at the maximum tolerated dose and have evaluable biopsy specimen.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to day of surgery

Descriptive statistics (e.g., mean, standard deviation) will be given for the ipatasertib pharmacokinetics measured in the tissue and blood. Graphs and non-linear model techniques will be used to describe and identify the maximum plasma concentration (Cmax) and the time to observed Cmax (Tmax) for ipatasertib whenever these are applied.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 90 days

Assessed by RECIST 1.1, and measurements for genomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1). Summary statistics (or graphs) for PTEN loss, genomic alterations in PI3K pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1), transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1) will be given. The association of objective tumor response with each of these biomarkers will be explored by appropriate statistical methods, e.g., Spearman's rank correlation coefficient for ordinal or interval type of biomarker data, chi-squared test for nominal type of biomarker data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 90 days

Assessed by RECIST 1.1, and measurements for transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1). Summary statistics (or graphs) for PTEN loss, genomic alterations in PI3K pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1), transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1) will be given. The association of objective tumor response with each of these biomarkers will be explored by appropriate statistical methods, e.g., Spearman's rank correlation coefficient for ordinal or interval type of biomarker data, chi-squared test for nominal type of biomarker data.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 90 days

Assessed by RECIST 1.1, and measurement for PTEN loss. Summary statistics (or graphs) for PTEN loss, genomic alterations in PI3K pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1), transcriptomic alterations in PI3K Pathway genes (PTEN, PI3KCA, PIK3R1, AKT1, p53 loss, KRAS, NF1, TSC1/TSC1) will be given. The association of objective tumor response with each of these biomarkers will be explored by appropriate statistical methods, e.g., Spearman's rank correlation coefficient for ordinal or interval type of biomarker data, chi-squared test for nominal type of biomarker data.

Outcome measures

Outcome data not reported

Adverse Events

DL1 Dose Escalation Cohort

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

DL1 Dose Expansion-only Cohort

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

DL2 Dose Escalation Cohort

Serious events: 5 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	DL1 Dose Escalation Cohort n=7 participants at risk Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL1 Dose Expansion-only Cohort n=13 participants at risk Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=5 participants at risk Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Cardiac disorders Cardiac Arrest	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Diarrhea	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Death Nos	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Sepsis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Neutrophil Count Decreased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Aspartate Aminotransferase Increased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Syncope	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Vascular disorders Thromboembolic Event	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.

Other adverse events

Measure	DL1 Dose Escalation Cohort n=7 participants at risk Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL1 Dose Expansion-only Cohort n=13 participants at risk Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 200 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.	DL2 Dose Escalation Cohort n=5 participants at risk Paclitaxel at 175 mg/m2 was administered intravenously over 3 hours, and carboplatin at AUC 5 was administered intravenously over 30-60 minutes on Day 1 of each 21-day treatment cycle. Treatment was repeated every 21 days for up to 3 cycles, in the absence of disease progression or unacceptable toxicity. Concurrently, ipatasertib was administered orally at a dose of 300 mg once daily and continued until 24 hours prior to surgery, unless disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Blood and lymphatic system disorders Anemia	57.1% 4/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	23.1% 3/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	100.0% 5/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Cardiac disorders Palpitations	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Cardiac disorders Sinus Tachycardia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Cardiac disorders Chest Pain - Cardiac	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Cardiac disorders Cardiac Arrest	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Cardiac disorders Heart Failure	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Diarrhea	57.1% 4/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	46.2% 6/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	100.0% 5/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Constipation	42.9% 3/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	38.5% 5/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	60.0% 3/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Colitis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Vomiting	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	80.0% 4/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Stomach Pain	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Bloating	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Nausea	57.1% 4/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	30.8% 4/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	80.0% 4/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Dysphagia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Abdominal Pain	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	23.1% 3/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Ileus	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Gastrointestinal disorders Belching	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Pain	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Malaise	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Fever	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders General Disorders And Administration Site Conditio	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Fatigue	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	38.5% 5/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	80.0% 4/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Gait Disturbance	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Edema Limbs	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
General disorders Death Nos	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Immune system disorders Allergic Reaction	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Tracheitis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Urinary Tract Infection	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	60.0% 3/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Thrush	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Sinusitis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Sepsis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Lung Infection	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Infections and infestations Infections And Infestations - Other	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Injury, poisoning and procedural complications Infusion Related Reaction	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Weight Loss	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Platelet Count Decreased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	60.0% 3/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Cholesterol High	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Neutrophil Count Decreased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	60.0% 3/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Lymphocyte Count Decreased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Inr Increased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Electrocardiogram T Wave Abnormal	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Electrocardiogram Qt Corrected Interval Prolonged	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Ejection Fraction Decreased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Creatinine Increased	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Cardiac Troponin T Increased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Blood Bilirubin Increased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations White Blood Cell Decreased	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	60.0% 3/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Blood Bicarbonate Decreased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Aspartate Aminotransferase Increased	42.9% 3/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Alkaline Phosphatase Increased	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	23.1% 3/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Alanine Aminotransferase Increased	42.9% 3/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Investigations Activated Partial Thromboplastin Time Prolonged	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypokalemia	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	100.0% 5/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	80.0% 4/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypertriglyceridemia	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	60.0% 3/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Hyperglycemia	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	23.1% 3/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Anorexia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Alkalosis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Metabolism and nutrition disorders Acidosis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Bone Pain	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Back Pain	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Arthralgia	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Vascular disorders Hypertension	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Syncope	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Peripheral Sensory Neuropathy	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Nervous System Disorders - Other	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Paresthesia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	23.1% 3/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Dysgeusia	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Dizziness	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Nervous system disorders Concentration Impairment	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Renal And Urinary Disorders - Other	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Proteinuria	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Urinary Incontinence	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Urinary Urgency	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Hematuria	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Glucosuria	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Renal and urinary disorders Dysuria	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Sore Throat	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Respiratory, thoracic and mediastinal disorders Adult Respiratory Distress Syndrome	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	57.1% 4/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Pruritus	28.6% 2/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Nail Discoloration	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Erythema Multiforme	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Skin and subcutaneous tissue disorders Alopecia	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	15.4% 2/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Vascular disorders Vascular Disorders - Other	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Vascular disorders Thromboembolic Event	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	20.0% 1/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Vascular disorders Hypotension	0.00% 0/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	7.7% 1/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	40.0% 2/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.
Vascular disorders Flushing	14.3% 1/7 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/13 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.	0.00% 0/5 • During treatment period and up to 90 days after the last dose of ipatasertib. The median for duration of study treatment was 68 days with a range from 1 day to 90 days. Participants who received any amount of protocol therapy.

Additional Information

Helen Huang on behalf of Wei Deng, PhD.

NRG Oncology

Phone: (716) 845-1300

Email: huangh@nrgoncology.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60