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This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab (Avastin) | Active Comparator | Avastin® + Carboplatin/Paclitaxel |
|
| SB8 (A proposed bevacizumab biosimilar) | Experimental | SB8 + Carboplatin/Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Avastin® 15 mg/kg IV every 3 weeks on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks | The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | 24 weeks from randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | PFS is defined as the time from the date of Randomisation to the date of disease progression (progressive disease [PD]) or death regardless of the cause of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Measure | Description | Time Frame |
|---|---|---|
| Best Objective Response Rate by 11 and 17 Weeks | Best Objective Response Rate (ORR) by 11 weeks and 17 weeks | 11 weeks and 17 weeks from randomisation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Reck, M.D. | LungenClinic Grosshansdorf, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brest Regional Oncology Dispensary | Brest | 224027 | Belarus | |||
| Grodno Regional Clinical Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab (Avastin) | Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
| FG001 | SB8 (A Proposed Bevacizumab Biosimilar) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2016 | Jul 1, 2022 |
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| SB8 | Drug | SB8 15 mg/kg IV every 3 weeks on Day 1 |
|
|
| Carboplatin | Drug | Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles |
|
| Paclitaxel | Drug | Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
|
|
| from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject |
| Overall Survival | OS was defined as the time from the date of randomisation to the date of death regardless of the cause of death. Subjects who were alive at the time of analysis were censored at the date of last known alive. | from the date of randomisation to the date of death up to 12 months from randomisation of the last subject |
| Duration of Response (DoR) | DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject | from documented tumour response until disease progression up to 12 months from randomisation of the last subject |
| Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 | After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE | AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation. |
| Pharmacokinetics: Trough Level [Ctrough] | Ctrough at selected cycles (i.e., Cycle 1, 3, 5 and 7) | Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) |
| Pharmacokinetics: Maximum Plasma Concentration [Cmax] | Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7) | Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) |
| Immunogenicity Assessments (Anti-drug Antibodies) | Incidence of anti-drug (bevacizumab) antibodies (ADA) The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below:
| Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation. |
| Immunogenicity Assessments (Neutralizing Antibodies) | Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF. The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary. Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies). | Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation. |
| Grodno |
| 230017 |
| Belarus |
| N. N. Alexandrov Republican Scientific and Practical Center of Oncology and Medical Radiology | Lesnoy | 223040 | Belarus |
| Minsk city Clinical Oncological Dispensary | Minsk | 220013 | Belarus |
| Mogilev Regional Oncological Dispensary | Mogilev | 212018 | Belarus |
| Vitebsk Regional Clinical Oncological Dispensary | Vitebsk | 210603 | Belarus |
| JSC Maritime Hospital | Batumi | 6010 | Georgia |
| JSC Saint Nikolozi Surgery Center | Kutaisi | 4600 | Georgia |
| LTD Research Institute of Clinical Medicine | Tbilisi | 0112 | Georgia |
| ICO-Institute of Clinical Oncology | Tbilisi | 0159 | Georgia |
| New Vision University Hospital | Tbilisi | 0159 | Georgia |
| LTD MediClubGeorgia | Tbilisi | 0160 | Georgia |
| Institute for Personalized Medicine LTD | Tbilisi | 0186 | Georgia |
| LTD Chemotherapy and Immunotherapy Clinic Medulla | Tbilisi | 0186 | Georgia |
| Evangelisches Krankenhaus Bielefeld | Bielefeld | 33611 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| LungenClinic Grosshansdorf GmbH | Großhansdorf | 22927 | Germany |
| University Hospital Homburg | Homburg | 66421 | Germany |
| Klinikum Kassel | Kassel | 34125 | Germany |
| Universitätsklinikum Leipzig [Pneumologie] | Leipzig | 04103 | Germany |
| Klinik Löwenstein | Löwenstein | 74245 | Germany |
| Klinikum der Stadt Ludwigshafen | Ludwigshafen | 67063 | Germany |
| Országos Korányi TBC és Pulmonológiai Intézet | Budapest | 1121 | Hungary |
| Országos Korányi TBC és Pulmonológiai Intézet | Budapest | 1521 | Hungary |
| Orszagos Koranyi Tbc Es Pulmonologiai Intezet, Iv. Tudobel | Budapest | H-1529 | Hungary |
| Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó | Deszk | 6772 | Hungary |
| Veszprem Megyei Onkormanyzat Tudogyogyintezete | Farkasgyepű | 8582 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint | Szolnok | 5004 | Hungary |
| Markusovszky Egyetemi Oktatókórház | Szombathely | H-9700 | Hungary |
| Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc | Olsztyn | 10-357 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | 05-400 | Poland |
| MED-POLONIA Sp.z o.o. | Poznan | 60-693 | Poland |
| Med Life | Bucharest | 031784 | Romania |
| Spitalul Universitar de Urgenta Bucuresti | Bucharest | 050098 | Romania |
| Medisprof | Cluj-Napoca | 400058 | Romania |
| Spitalul Clinic Judetean de Urgenta Constanta | Constanța | 900591 | Romania |
| Centrul de Oncologie Sf. Nectarie | Craiova | 200347 | Romania |
| Oncolab | Craiova | 200385 | Romania |
| Radiotherapy Center CJ radioterapie si chimioterapie adulti | Floreşti | 407280 | Romania |
| Centrul de Oncologie Euroclinic | Iași | 700106 | Romania |
| Institutul Regional de Oncologie Iasi | Iași | 700483 | Romania |
| Pelican Impex | Oradea | 410469 | Romania |
| Oncocenter Oncologie Clinica | Timișoara | 300210 | Romania |
| State Budgetary Institution of Arkhangelsk Oblast "Arkhangelsk Region Clinical Oncology Center | Arkhangelsk | 163045 | Russia |
| State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Oncology Center" | Chelyabinsk | 454087 | Russia |
| State Autonomous Healthcare Institution "Republican Clinical Oncology Center of Ministry of Healthcare of Tatarstan Republic" | Kazan' | 420029 | Russia |
| State Budgetary Healthcare Institution "Regional Clinical Hospital #1 n.a. professor S.V. Ochapovsky" of Ministry of Healthcare of Krasnodar Region | Krasnodar | 350086 | Russia |
| Federal State Budgetary Scientific Institution " N.N. Blokhin Russian Cancer Research Center" of the Ministry of Health of the Russian Federation | Moscow | 115478 | Russia |
| State Autonomous Healthcare Institution of Moscow "Moscow City Oncology Hospital # 62 of Healthcare Department of Moscow" | Moscow | 143423 | Russia |
| State Regional Budgetary Healthcare Institution "Murmansk Regional Oncology Center" | Murmansk | 183047 | Russia |
| State Budgetary Healthcare Institution of Nizhny Novgorod oblast "Nizhny Novgorod Region Oncology Center" | Nizhny Novgorod | 603081 | Russia |
| State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncology Center" | Novosibirsk | 630108 | Russia |
| Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Center" | Omsk | 644013 | Russia |
| Federal Budgetary Healthcare Insittution "Saint-Petersburg Clinical Hospital of RAS" | Saint Petersburg | 194017 | Russia |
| State Budgetary Healthcare Institution Leningradskaya Region Clinical Hospital | Saint Petersburg | 194291 | Russia |
| Federal State Budgetary Educational Institution of Higher Education "Academician I.P. Pavlov First St. Petersburg State Medical University" of the Ministry of Healthcare of the Russian Federation./ Scientific Research Institute of Pulmonology | Saint Petersburg | 197022 | Russia |
| Federal State Budgetary Institution " Scientific Research Institute of Oncology n.a. N.N. Petrov" of Ministry of Healthcare of the Russian Federation | Saint Petersburg | 197758 | Russia |
| Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Center" | Saint Petersburg | 198255 | Russia |
| Private foundation of Educational establishment of Higher Education Medical University "REAVIZ" | Samara | 443011 | Russia |
| State Budgetary Healthcare Institution " Oncology Center #2" of Krasnodar Region Ministry of Healthcare | Sochi | 354057 | Russia |
| State Budgetary Healthcare Institution Republican Clinical Oncology Center of Ministry of Healthcare of the Republic of Bashkortostan | Ufa | 450054 | Russia |
| State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Center" | Volzhskiy | 404130 | Russia |
| State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncology Hospital" | Yaroslavl | 150040 | Russia |
| State Budgetary Healthcare Institution of Sverdlovskaya Oblast "Sverdlovsk Regional Oncology Center" | Yekaterinburg | 620036 | Russia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | 11070 | Serbia |
| Clinical Center Kragujevac, Clinic for Pulmology | Kragujevac | 34000 | Serbia |
| Clinical Centre Nis | Niš | 18000 | Serbia |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| Gyeongsang National University Hospital | Jinju | 52727 | South Korea |
| CHA Bundang Medical Center, CHA University | Seongnam | 13496 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Gangnam Severance Hospital, Yonsei University Health System | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Catholic University of Korea, St. Vincent's Hospital | Suwon | 442-723 | South Korea |
| Yonsei Universtiy, Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| C.H. Provincial de Castellón | Castellon | 12002 | Spain |
| H.U. Severo Ochoa | Leganés | 28911 | Spain |
| H.G.U. G. Marañón | Madrid | 28007 | Spain |
| H.U. F. Jiménez Díaz | Madrid | 28040 | Spain |
| C.H. de Orense | Ourense | 32005 | Spain |
| Clínica Universidad de Navarra | Pamplona | 31008 | Spain |
| H.U. Sant Joan de Reus | Reus | 43204 | Spain |
| C.H.U. de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| H.U.N. Sra. Valme | Seville | 41014 | Spain |
| Changhua Christian Hospital | Changhua | 50006 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| E-Da Hospital | Kaohsiung City | 824 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Chang Gung Medical Foundation, Linkou | Taoyuan | 33305 | Taiwan |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| ChiangMai Univerisity | Chiang Mai | 50200 | Thailand |
| Chiangrai Prachanukroh Hospital | Chiang Rai | 57000 | Thailand |
| Prince of Songkla University | Hat Yai | 90110 | Thailand |
| Udonthani Cancer Hospital | Udon Thani | 41330 | Thailand |
| Komunalna ustanova "Chernivetskyi oblasnyi klinichnyi onkolo | Chernivtsi | 58013 | Ukraine |
| Komunalnyi zaklad Miska bahatoprofilna klinichna likarnia #4 | Dnipropetrovsk | 49102 | Ukraine |
| Kharkivskyi oblasnyi onkologichnyi klinichnyi tsentr | Kharkiv | 61070 | Ukraine |
| Khmelnytskyi oblasnyi onkolohichnyi dyspanser | Khmelnytskyi | 29009 | Ukraine |
| Odeskyi oblasnyi onkolohichnyi dyspanser | Odesa | 65055 | Ukraine |
| OKZ "Sumskyi oblasnyi klinichnyi onkolohichnyi dyspanser" | Sumy | 40022 | Ukraine |
| Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser | Vinnytsia | 21029 | Ukraine |
| Zaporozhye Regional Clinical Oncology Center | Zaporizhzhya | 69040 | Ukraine |
SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab (Avastin) | Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
| BG001 | SB8 (A Proposed Bevacizumab Biosimilar) | SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks | The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | The Full Analysis Set consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. However, subjects who did not qualify for randomisation and were inadvertently randomised into the study were excluded from FAS, provided these subjects did not receive any IP, and there was one subject who met these criteria. So, there is a difference between "Started" in Participant Flow module and Analysis Population. | Posted | Number | percentage of participants | 24 weeks from randomisation |
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| Secondary | Progression Free Survival | PFS is defined as the time from the date of Randomisation to the date of disease progression (progressive disease [PD]) or death regardless of the cause of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Full Analysis Set (FAS): Consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. Per-protocol Set (PPS): Consisted of all FAS subjects who completed at least first 2 cycles of combination chemotherapy with a tumour assessment and did not have any major protocol deviations that impacted the primary efficacy assessment. | Posted | Median | 95% Confidence Interval | months | from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject |
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| Secondary | Overall Survival | OS was defined as the time from the date of randomisation to the date of death regardless of the cause of death. Subjects who were alive at the time of analysis were censored at the date of last known alive. | Full Analysis Set (FAS): Consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. Per-protocol Set (PPS): Consisted of all FAS subjects who completed at least first 2 cycles of combination chemotherapy with a tumour assessment and did not have any major protocol deviations that impacted the primary efficacy assessment. | Posted | Median | 95% Confidence Interval | months | from the date of randomisation to the date of death up to 12 months from randomisation of the last subject |
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| Secondary | Duration of Response (DoR) | DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject | Full Analysis Set (FAS): Consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. Per-protocol Set (PPS): Consisted of all FAS subjects who completed at least first 2 cycles of combination chemotherapy with a tumour assessment and did not have any major protocol deviations that impacted the primary efficacy assessment. | Posted | Mean | Standard Deviation | months | from documented tumour response until disease progression up to 12 months from randomisation of the last subject |
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| Secondary | Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 | After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE | Safety Set (SAF): The Safety Set consisted of all subjects who received the study drug at least once. | Posted | Count of Participants | Participants | AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 months from study initiation. |
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| Secondary | Pharmacokinetics: Trough Level [Ctrough] | Ctrough at selected cycles (i.e., Cycle 1, 3, 5 and 7) | Pharmacokinetic Population (PK Population): This set consisted of subjects allocated to PK sub-study who had at least one measured serum concentration of bevacizumab. PK analyses were performed on the PK population. The number of participants analyzed in each Cycle is the number of participants in PK population with non-missing values or without protocol deviation for PK blood sampling at the cycle. | Posted | Mean | Standard Deviation | ug/mL | Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) |
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| Secondary | Pharmacokinetics: Maximum Plasma Concentration [Cmax] | Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7) | Pharmacokinetic Population (PK Population): This set consisted of subjects allocated to PK sub-study who had at least one measured serum concentration of bevacizumab. PK analyses were performed on the PK population. The number of participants analyzed in each Cycle is the number of participants in PK population with non-missing values or without protocol deviation for PK blood sampling at the cycle. | Posted | Mean | Standard Deviation | ug/mL | Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) |
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| Secondary | Immunogenicity Assessments (Anti-drug Antibodies) | Incidence of anti-drug (bevacizumab) antibodies (ADA) The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below:
| The analysis was performed using the Safety Set (SAF). The SAF consisted of all subjects who received the study drug at least once. This analysis set was used for the safety analyses. The subjects were analysed based on the treatment they received. There were 4 subjects in Avastin group and 1 subject in SB8 group who had not received any IP or non-IP treatment. | Posted | Count of Participants | Participants | Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation. |
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| Secondary | Immunogenicity Assessments (Neutralizing Antibodies) | Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF. The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary. Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies). | The analysis was performed using the Safety Set (SAF). The SAF consisted of all subjects who received the study drug at least once. This analysis set was used for the safety analyses. The subjects were analysed based on the treatment they received. There were 4 subjects in Avastin group and 1 subject in SB8 group who had not received any IP or non-IP treatment. | Posted | Count of Participants | Participants | Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation. |
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| Other Pre-specified | Best Objective Response Rate by 11 and 17 Weeks | Best Objective Response Rate (ORR) by 11 weeks and 17 weeks | Full Analysis Set (FAS): Consisted of all randomised subjects. The subjects were analysed based on the treatment they were randomised to by intention-to-treat principle. Per-protocol Set (PPS): Consisted of all FAS subjects who completed at least first 2 cycles of combination chemotherapy with a tumour assessment and did not have any major protocol deviations that impacted the primary efficacy assessment. | Posted | Count of Participants | Participants | 11 weeks and 17 weeks from randomisation |
|
|
AEs were reported from the time the ICF was signed until the EOT visit, approximately 24 months from study initiation.
All safety analyses were performed using the Safety Set (SAF). The SAF consisted of all subjects who received the study drug at least once. This analysis set was used for the safety analyses. The subjects were analysed based on the treatment they received.
There were 4 subjects in Avastin group and 1 subject in SB8 group who had not received any IP or non-IP treatment.
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 | Bevacizumab (Avastin) | Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles | 171 | 380 | 81 | 380 | 316 | 380 |
| EG001 | SB8 (A Proposed Bevacizumab Biosimilar) | SB8 + Carboplatin/Paclitaxel SB8: SB8 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles | 166 | 378 | 75 | 378 | 323 | 378 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Optic atrophy | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastric hypomotility | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Suture rupture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Brachial plexopathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cystitis glandularis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Internal haemorrhage | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd | 031-8061-1096 | sbregistry@samsung.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2018 | Jul 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Bevacizumab (Avastin) | Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
|
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
| OG001 | Bevacizumab (Avastin) | Avastin® + Carboplatin/Paclitaxel Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1 Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
|
|
Avastin® + Carboplatin/Paclitaxel
Bevacizumab: Avastin® 15 mg/kg IV every 3 weeks on Day 1
Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
|
|
| Participants |
|
|
| Negative |
|
| Inconclusive (only applicable for "Overall") |
|
| Negative |
|
| Inconclusive (only applicable for "Overall") |
|
| Negative |
|
| Inconclusive (only applicable for "Overall") |
|
| Negative |
|
| Inconclusive (only applicable for "Overall") |
|
| Negative |
|
| Inconclusive (only applicable for "Overall") |
|
| Negative |
|
| Inconclusive (only applicable for "Overall") |
|
| Negative |
|
| Negative |
|
| Negative |
|
| Negative |
|