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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002080-10 | EudraCT Number |
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This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib + mFOLFOX6 | Experimental | Participants will receive oral ipatasertib on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6, administered on Day 1 of each cycle. |
|
| Placebo + mFOLFOX6 | Placebo Comparator | Participants will receive the placebo equivalent to ipatasertib on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6, administered on Day 1 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Fluorouracil | Drug | Participants will receive bolus and infusional 5-fluorouracil on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. The infusion times for infusional 5-fluorouracil may be determined per local and/or institutional standards and product labeling. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in All Randomized Participants and Participants With PTEN Loss Tumors at Primary Analysis | PFS was defined as the time from randomization to the first occurrence of disease progression (as determined using RECIST Version 1.1 and assessed by the investigator), or death from any cause on study. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or progression of non-target lesions. Death on study was defined as death from any cause within 30 days of the last dose of study treatment regimen. Kaplan-Meier estimates were used for evaluation. | Screening, at the end of Cycle 4 (cycle = 14 days) and every fourth cycle thereafter until disease progression or death, whichever occurred first, assessed up to approximately 1.75 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. Kaplan-Meier estimates were used for evaluation. | Baseline up to end of study (up to approximately 7.5 years) |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ of Calif, Los Angeles; Hematology/Oncology | Los Angeles | California | 90095 | United States | ||
| Massachusetts General Hospital;Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30592991 | Derived | Bang YJ, Kang YK, Ng M, Chung HC, Wainberg ZA, Gendreau S, Chan WY, Xu N, Maslyar D, Meng R, Chau I, Ajani JA. A phase II, randomised study of mFOLFOX6 with or without the Akt inhibitor ipatasertib in patients with locally advanced or metastatic gastric or gastroesophageal junction cancer. Eur J Cancer. 2019 Feb;108:17-24. doi: 10.1016/j.ejca.2018.11.017. Epub 2018 Dec 25. |
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Total 153 participants were randomized in this study, of which 152 participants received treatment.
The study was conducted at 33 centers in 11 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipatasertib + mFOLFOX6 | Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ipatasertib | Drug | Participants will receive ipatasertib, 600 milligrams (mg) orally once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity. |
|
| Leucovorin | Drug | Participants will receive leucovorin or equivalent substitute orally, on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. |
|
| Oxaliplatin | Drug | Participants will receive oxaliplatin via intravenous (IV) infusion on Day 1 of each 14-day cycle (part of mFOLFOX6 therapy). Oxaliplatin will be discontinued after completion of 8 cycles |
|
| Placebo | Drug | Participants will receive matching oral placebo capsules once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity. |
|
Objective Response Rate was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) based on the investigator assessment using RECIST v 1.1. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. |
| Screening, at the end of Cycle 4 (cycle = 14 days) and every fourth cycle thereafter until disease progression or death, whichever occurred first, up to end of study (up to approximately 7.5 years) |
| Duration of Objective Tumor Response | Duration of objective tumor response in participants with measurable soft tissue 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 Version 1.1. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or progression of non-target lesions. | Screening, at the end of Cycle 4 (cycle = 14 days) and every fourth cycle thereafter until disease progression or death, whichever occurred first, up to end of study (up to approximately 7.5 years) |
| Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Death on study was defined as death from any cause within 30 days of the last dose of study treatment regimen. | Baseline until end of study (up to approximately 7.5 years) |
| Serum Concentration of Ipatasertib | Day 1 at 1 hour and 4 hours post-dose; Day 5, pre-dose and 2 hours post-dose |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Institut Gustave Roussy; Departement Oncologie Medicale | Villejuif | 94805 | France |
| Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo. | Berlin | 10117 | Germany |
| Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie | Hanover | 30625 | Germany |
| Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen | Heidelberg | 69120 | Germany |
| Queen Mary Hospital; Dept. of Clinical Oncology | Hong Kong | Hong Kong |
| IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A | Genoa | Liguria | 16132 | Italy |
| Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica | Pisa | Tuscany | 56126 | Italy |
| IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto | 35128 | Italy |
| Hospital Universiti Sains Malaysia [Neurology] | Kubang Kerian | Kelantan | 16150 | Malaysia |
| Gleneagles Medical Centre | George Town | 10050 | Malaysia |
| University Malaya Medical Centre; Clinical Oncology Unit, | Kuala Lumpur | 59100 | Malaysia |
| National Cancer Centre; Medical Oncology | Singapore | 169610 | Singapore |
| Oncocare Cancer Centre | Singapore | 258499 | Singapore |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Gachon Medical School Gil Medical Centre; Internal Medicine | Incheon | 405-760 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Asan Medical Center; Medical Oncology | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul National University Hosp; Dept Internal Med Hem Onc | Seoul | 110-744 | South Korea |
| Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept. | Seoul | 120-752 | South Korea |
| St Vincent'S Hospital; Oncology | Suwon | South Korea |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| National Cheng Kung Univ Hosp | Tainan | 00704 | Taiwan |
| National Taiwan Uni Hospital; Dept of Oncology | Taipei | 100 | Taiwan |
| Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology | Taoyuan | 333 | Taiwan |
| Royal Marsden Hospital; Dept of Med-Onc | London | SW3 6JJ | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| Mount Vernon Hospital; Centre For Cancer Treatment | Northwood | HA6 2RN | United Kingdom |
| The Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| FG001 | Placebo + mFOLFOX6 | Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ipatasertib + mFOLFOX6 | Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
| BG001 | Placebo + mFOLFOX6 | Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| 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) in All Randomized Participants and Participants With PTEN Loss Tumors at Primary Analysis | PFS was defined as the time from randomization to the first occurrence of disease progression (as determined using RECIST Version 1.1 and assessed by the investigator), or death from any cause on study. Progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or progression of non-target lesions. Death on study was defined as death from any cause within 30 days of the last dose of study treatment regimen. Kaplan-Meier estimates were used for evaluation. | The randomized population was defined as all participants who were randomized in the study. Randomized participants with PTEN loss tumors were also analyzed. For the primary analysis, PTEN loss was defined as the condition "Perc Cells Cytoplasmic Stain Int 0" of greater than or equal to 10. | Posted | Median | 90% Confidence Interval | months | Screening, at the end of Cycle 4 (cycle = 14 days) and every fourth cycle thereafter until disease progression or death, whichever occurred first, assessed up to approximately 1.75 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of randomization to the date of death from any cause. Kaplan-Meier estimates were used for evaluation. | All randomized participants, randomized participants with PTEN loss tumors and randomized participants who were Akt diagnostic-positive (Akt Dx+) were analyzed. For the final analysis, PTEN loss was defined as the condition "Perc Cells Cytoplasmic Stain Int 0" of greater than 10. | Posted | Median | 90% Confidence Interval | months | Baseline up to end of study (up to approximately 7.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | Objective Response Rate was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) based on the investigator assessment using RECIST v 1.1. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions. | All randomized participants, randomized participants with PTEN loss tumors and randomized participants who were Akt diagnostic-positive (Akt Dx+) were analyzed. For the final analysis, PTEN loss was defined as the condition "Perc Cells Cytoplasmic Stain Int 0" of greater than 10. | Posted | Number | 90% Confidence Interval | percentage of participants | Screening, at the end of Cycle 4 (cycle = 14 days) and every fourth cycle thereafter until disease progression or death, whichever occurred first, up to end of study (up to approximately 7.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Objective Tumor Response | Duration of objective tumor response in participants with measurable soft tissue 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 Version 1.1. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or progression of non-target lesions. | All randomized participants, randomized participants with PTEN loss tumors and randomized participants who were Akt diagnostic-positive (Akt Dx+) were analyzed. For the final analysis, PTEN loss was defined as the condition "Perc Cells Cytoplasmic Stain Int 0" of greater than 10. | Posted | Median | 90% Confidence Interval | months | Screening, at the end of Cycle 4 (cycle = 14 days) and every fourth cycle thereafter until disease progression or death, whichever occurred first, up to end of study (up to approximately 7.5 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Death on study was defined as death from any cause within 30 days of the last dose of study treatment regimen. | The safety population was defined as all randomized participants who received at least one dose of ipatasertib/placebo or mFOLFOX6, with participants grouped according to the treatment actually received. | Posted | Count of Participants | Participants | Baseline until end of study (up to approximately 7.5 years) |
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| Secondary | Serum Concentration of Ipatasertib | The pharmacokinetic (PK) population was defined as all participants with evaluable PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 1 at 1 hour and 4 hours post-dose; Day 5, pre-dose and 2 hours post-dose |
|
|
Baseline until end of study (up to approximately 7.5 years)
Safety population included treated participants (i.e., participants who received at least one dose of ipatasertib/placebo or mFOLFOX6), with participants allocated to the treatment arm associated with the regimen that they actually received.
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 + mFOLFOX6 | Ipatasertib was administered at a dose of 600 milligrams (mg) orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following ipatasertib administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 milligram per square-meter (mg/m^2) intravenous (IV) infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-fluorouracil (5-FU) as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. | 57 | 70 | 39 | 70 | 70 | 70 |
| EG001 | Placebo + mFOLFOX6 | Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. | 59 | 82 | 36 | 82 | 79 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ULCERATIVE KERATITIS | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INTESTINAL PSEUDO-OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| JEJUNAL PERFORATION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LARGE INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OBSTRUCTION GASTRIC | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OESOPHAGEAL FISTULA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OBSTRUCTION | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BILIARY OBSTRUCTION | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| JAUNDICE CHOLESTATIC | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| LARGE INTESTINE INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| CHEMICAL PERITONITIS | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| CACHEXIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FAILURE TO THRIVE | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| CEREBRAL GAS EMBOLISM | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIABETIC HYPEROSMOLAR COMA | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PARAPARESIS | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RENAL COLIC | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY TRACT DISORDER | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PNEUMONIA ASPIRATION | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VENOUS THROMBOSIS | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GRANULOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TEMPERATURE INTOLERANCE | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| GLYCOSYLATED HAEMOGLOBIN INCREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 23.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| FLANK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| TASTE DISORDER | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN DISCOLOURATION | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| SKIN HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 23.1 | 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 |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| C583616 | ipatasertib |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| White |
|
| Other |
|
| Unknown |
|
| Participants With PTEN Loss Tumors |
|
|
| Log Rank |
| = 0.86 |
| Hazard Ratio (HR) |
| 1.07 |
| 2-Sided |
| 90 |
| 0.54 |
| 2.11 |
| Superiority |
Unstratified analysis |
|
|
|
| OG001 | Placebo + mFOLFOX6 | Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
|
|
|
| OG001 | Placebo + mFOLFOX6 | Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
|
|
|
| OG001 | Placebo + mFOLFOX6 | Placebo matched to ipatasertib was administered orally once daily, beginning on Day 1 of Cycle 1 through Day 7 of each 14-day cycle until the participant experienced disease progression or intolerable toxicity. Following placebo administration on Day 1 of each cycle, the participant then received mFOLFOX6 in the following order: oxaliplatin as an 85 mg/m^2 IV infusion on Day 1 every 14 days with co-administration of leucovorin at 400 mg/m^2 or equivalent substitute. The participant then received 5-FU as a 400 mg/m^2 bolus infusion followed by 5-FU as a 2400 mg/m^2 continuous IV infusion (or 5-FU as a 1200 mg/m^2/day continuous IV infusion). Following Cycle 8, oxaliplatin was discontinued. |
|
|
|