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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000469-35 | EudraCT Number |
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This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib + Paclitaxel | Experimental | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
| Placebo + Paclitaxel | Placebo Comparator | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first. | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) |
| PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first. | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Jude Heritage Medical Group | Fullerton | California | 92835 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28800861 | Derived | Kim SB, Dent R, Im SA, Espie M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. doi: 10.1016/S1470-2045(17)30450-3. Epub 2017 Aug 8. |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 166 participants were screened, out of which 42 participants failed screening. A total of 124 participants were enrolled at 44 sites. Results are reported here up to clinical cut-off date of 31st August 2019.
The study was conducted at 44 centers in 8 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipatasertib and Paclitaxel | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paclitaxel | Drug | Participants received paclitaxel 80 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, and 15 of each cycle. |
|
| Placebo | Drug | Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle. |
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| Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) |
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019) |
| OS in Participants With PTEN-Low Tumors | OS was defined as the time from the date of randomization to the date of death from any cause. | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019) |
| OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors | OS was defined as the time from the date of randomization to the date of death from any cause. | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019) |
| Objective Response Rate (ORR) | Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| ORR in Participants With PTEN-Low Tumors | Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors | Confirmed tumor ORR in subjects with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of subjects who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Subjects for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Duration of Response | Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Duration of Response in Participants With PTEN-Low Tumors | Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors | Duration of objective response in participants with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Time to Disease Progression | Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Time to Disease Progression in Participants With PTEN-Low Tumors | Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors | Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1. | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
| Safety: Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months) |
| Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib | PK parameters were not calculated due to sparse PK sampling. | Cycle 1 Day 1, Cycle 1 Day 8 |
| Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib | PK parameters were not calculated due to sparse PK sampling. | Cycle 1 Day 1, Cycle 1 Day 8 |
| Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score | EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1=Not at all to 4=Very much; 2 questions used 7-point scale [1=very poor to 7=Excellent]). Scores averaged, transformed to 0-100 scale; a higher score=better level of functioning. For symptom scale scores, higher level=severe level of symptoms. "A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). PRO measures were analyzed from baseline up to cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5). | Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1 |
| PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30 | Subjects reporting >/= 10-point increase compared to baseline (Cycle 1 Day 1) were considered "improved", those reporting <10-point difference were considered "remained stable", and those reporting >/=10-point decrease were considered "worsened". A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). Patient reported outcome measures were analyzed from baseline up to and including cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5). | Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Cancer Care Assoc Med Group | Los Angeles | California | 90095-1772 | United States |
| UCLA Medical Center | Santa Monica | California | 90404 | United States |
| Holycross Medical Group | Fort Lauderdale | Florida | 33308 | United States |
| Memorial Healthcare System | Hollywood | Florida | 33021 | United States |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214-3728 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89014 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28208 | United States |
| The WEST CLINIC, P.C. | Memphis | Tennessee | 38119 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Northern Utah Associates | Ogden | Utah | 84403 | United States |
| Northwest Medical Specialties | Lakewood | Washington | 98499 | United States |
| West Virginia University Hospitals Inc | Morgantown | West Virginia | 26056 | United States |
| Sint Augustinus Wilrijk | Wilrijk | 2610 | Belgium |
| Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest | Bordeaux | 33076 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque | Montpellier | 34298 | France |
| Hopital Saint Louis; Oncologie Medicale | Paris | 75475 | France |
| Clinique Armoricaine de Radiol | Saint-Brieuc | 22015 | France |
| Istituto Nazionale Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica | Milan | Lombardy | 20133 | Italy |
| Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera | Padova | Veneto | 35128 | Italy |
| National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | 119228 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| MD Anderson Cancer Center | Madrid | 28033 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Farmacia | Madrid | 28050 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| China Medical University Hospital | North Dist. | 40402 | Taiwan |
| Chi Mei Medical Center, Yong kang; Endocrinology | Tainan | 710 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Dept of Surgery | Taoyuan | 333 | Taiwan |
| Placebo and Paclitaxel |
Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipatasertib and Paclitaxel | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| BG001 | Placebo and Paclitaxel | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first. | The Intent to treat (ITT) population was defined as all randomized participants allocated to the treatment arm to which they were randomized. | Posted | Median | 90% Confidence Interval | Months | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) |
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| Primary | PFS in Participants With Phosphatase and Tensin Homolog (PTEN)-Low Tumors | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first. | The ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint. | Posted | Median | 90% Confidence Interval | Months | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | PFS in Participants With Phosphatidylinositol-4,5-bisphosphate 3-kinase Catalytic Subunit Alpha (PIK3CA)/ Protein Kinase B (AKT1)/ PTEN-altered Tumors | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (<=30 days after the last dose of study treatment regimen) from any cause, whichever occurred first. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. | Posted | Median | 90% Confidence Interval | Months | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019) |
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| Secondary | OS in Participants With PTEN-Low Tumors | OS was defined as the time from the date of randomization to the date of death from any cause. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint. | Posted | Median | 95% Confidence Interval | months | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019) |
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| Secondary | OS in Participants With PIK3CA/AKT1/PTEN-altered Tumors | OS was defined as the time from the date of randomization to the date of death from any cause. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. | Posted | Median | 95% Confidence Interval | months | Baseline up to 30 days after the last dose of study drug administration (Clinical Cut Off Date: 31 August 2019) |
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| Secondary | Objective Response Rate (ORR) | Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The Intent to treat (ITT) population was defined as all randomized participants allocated to the treatment arm to which they were randomized. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | ORR in Participants With PTEN-Low Tumors | Confirmed tumor ORR in participants with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of participants who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Participants for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-Low Tumors were evaluated for this endpoint. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | ORR in Participants With PIK3CA/AKT1/PTEN-altered Tumors | Confirmed tumor ORR in subjects with measurable disease at baseline was assessed by the investigator per RECIST, v1.1. Confirmed ORR was defined as the percentage of subjects who achieved either a complete response or partial response based on the investigator assessment that was confirmed by a repeat assessment no less than 4 weeks after the criteria for response was first met. Subjects for whom no records of post-baseline tumor assessments were reported were counted as non-responders. Complete response (CR): disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Duration of Response | Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1. | The ITT population was defined as all randomized participants allocated to the treatment arm to which they were randomized. Only participants who achieved a confirmed objective response were included in the analysis. | Posted | Median | 90% Confidence Interval | months | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Duration of Response in Participants With PTEN-Low Tumors | Duration of objective response in subjects with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1. | ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN-low tumors were evaluated for this endpoint. Only participants who achieved a confirmed objective response were included in the analysis. | Posted | Median | 90% Confidence Interval | Months | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Duration of Response in Participants With PIK3CA/AKT1/PTEN-altered Tumors | Duration of objective response in participants with measurable disease at baseline was defined as the time from first observation of an objective tumor response until first observation of disease progression, as assessed by the investigator per modified RECIST, v1.1. | ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. Only participants who achieved a confirmed objective response were included in the analysis. | Posted | Median | 90% Confidence Interval | Months | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Time to Disease Progression | Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1. | ITT population included all randomized participants allocated to the treatment arm to which they were randomized. | Posted | Median | 90% Confidence Interval | Months | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Time to Disease Progression in Participants With PTEN-Low Tumors | Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1. | ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PTEN low tumors were evaluated for this endpoint. | Posted | Median | 90% Confidence Interval | Months | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Time to Disease Progression in Participants With PIK3CA/AKT1/PTEN-altered Tumors | Time to disease progression was defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1. | ITT population included all randomized participants allocated to the treatment arm to which they were randomized. Participants with PIK3CA/AKT1/PTEN-altered tumors were evaluated for this endpoint. | Posted | Median | 90% Confidence Interval | Months | Baseline up to every 8 weeks until documented disease progression (Clinical Cut Off Date: 07 June 2016) |
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| Secondary | Safety: Percentage of Participants With Adverse Events | An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | The Safety population included all treated participants with participants allocated to the treatment arm associated with the regimen that they actually received. | Posted | Number | Percentage of Participants | Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months) |
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| Secondary | Pharmacokinetic Endpoint: Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) of Ipatasertib | PK parameters were not calculated due to sparse PK sampling. | The PK Analysis population was defined as all participants who had evaluable PK data. | Posted | Number | h*ng/mL/mg | Cycle 1 Day 1, Cycle 1 Day 8 |
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| Secondary | Pharmacokinetic Endpoint: Apparent Clearance Following Oral Dosing (CL/F) of Ipatasertib | PK parameters were not calculated due to sparse PK sampling. | The PK Analysis population was defined as all participants who had evaluable PK data. | Posted | Number | ml/hr | Cycle 1 Day 1, Cycle 1 Day 8 |
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| Secondary | Patient Reported Outcome (PRO) Measure: Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) Score | EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1=Not at all to 4=Very much; 2 questions used 7-point scale [1=very poor to 7=Excellent]). Scores averaged, transformed to 0-100 scale; a higher score=better level of functioning. For symptom scale scores, higher level=severe level of symptoms. "A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). PRO measures were analyzed from baseline up to cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5). | The PRO Analysis population was defined as the ITT population with a baseline and at least one post baseline PRO assessment. Data presented below is only for participants included in the actual analysis. | Posted | Mean | Standard Deviation | unit on a scale | Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1 |
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| Secondary | PRO Measure: Percentage of Participants With Improved, Worsened, or Remained Stable for Bothersome Side Effects of Treatment Measured by the Scales of the EORTC QLQ-C30 | Subjects reporting >/= 10-point increase compared to baseline (Cycle 1 Day 1) were considered "improved", those reporting <10-point difference were considered "remained stable", and those reporting >/=10-point decrease were considered "worsened". A change of at least 10 points from baseline is considered clinically meaningful (Osoba D, Rodrigues G, Myles J, et al. Interpreting the significance of changes in health-related quality of life score. J Clin Oncol 1998;16:139-44). Patient reported outcome measures were analyzed from baseline up to and including cycle 5. Scores from later timepoints were not analyzed due to attrition (in both arms, fewer than 50% of participants remained on treatment beyond cycle 5). | The PRO Analysis population was defined as the ITT population with a baseline and at least one post baseline PRO assessment. Data presented below is only for participants included in the actual analysis. | Posted | Number | Percentage of Participants | Baseline (Cycle 1 Day 1) up to Cycle 5 Day 1 |
|
Baseline up to 30 days after the last dose of study drug or until initiation of another anti-cancer therapy, whichever occurs first (up to 3 years, 3 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ipatasertib and Paclitaxel | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with ipatasertib 400 mg, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. | 41 | 61 | 18 | 61 | 61 | 61 |
| EG001 | Placebo and Paclitaxel | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. | 46 | 62 | 12 | 62 | 59 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Atypical Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Retroperitoneal Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Cell Death | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Spinal Cord Compression | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Triple negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nail Disorder | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583616 | ipatasertib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
| Black or African American |
|
| White |
|
| Other |
|
|
|
|
|
|
|
| Participants |
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|
|
| Counts |
|---|
| Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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|
Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|
| Placebo and Paclitaxel |
Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|
| Placebo and Paclitaxel |
Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
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| Units | Counts |
|---|---|
| Participants |
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|
|
| Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
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|
|
|
| OG001 | Placebo and Paclitaxel | Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|
Participants randomised to receive paclitaxel 80 mg/m^2, intravenously on Days 1, 8, and 15 along with placebo matching ipatasertib, orally, once daily from Days 1-21 in each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
|