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Sponsor discontinued development of CO-1686 for NSCLC.
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The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.
This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.
Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative.
All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.
The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rociletinib Mono-Therapy, T790M +ve (625mg BID) | Experimental | Starting dose of 625mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. |
|
| Rociletinib Mono-Therapy, T790M +ve (500mg BID) | Experimental | Starting dose of 500mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. |
|
| Rociletinib Mono-Therapy, T790M -ve (500mg BID) | Experimental | Starting dose of 500mg rociletinib, taken twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rociletinib | Drug | Rociletinib will be administered to patients orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) According to RECIST Version 1.1 as Determined by Investigator Assessment | ORR is defined as the percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is 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 the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Cycle 1 Day 1 to End of Treatment, up to approximately 57 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment | DOR in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis. |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Alhambra | California | 91801 | United States | ||
| Comprehensive Blood and Cancer Center |
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318 patients were enrolled at 67 study sites in North America, Europe, Asia and Australia. One patient was not included in the Safety Population due to failure of the study site to provide any dosing data in electronic data capture (EDC) before the site was closed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rociletinib 625 mg BID T790M+ | Rociletinib 625 mg BID in patients with T790M-positive tumor status |
| FG001 | Rociletinib 500 mg BID T790M+ | Rociletinib 500 mg BID in patients with T790M-positive tumor status |
| 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 16, 2016 | Jul 17, 2020 |
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|
| From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 54 months |
| Disease Control Rate (DCR) by RECIST v1.1 as Determined by Investigator Assessment | DCR is defined as the percentage of patients who have achieved CR, PR, and SD lasting at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is 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 the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months |
| Progression-free Survival (PFS) in T790M Positive Patients by RECIST v1.1 as Determined by Investigator Assessment | PFS was calculated as 1+ the number of days from the first dose of study drug to documented radiographic progression or death due to any cause, whichever occurs first. Patients without a documented event of radiographic progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments were performed. For patients who continued treatment post-progression, the first date of progression was used for the analysis of PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter 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. The appearance of one or more new lesions is also considered progression. | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months |
| Overall Survival (OS) Determined by Investigator Assessment | OS was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death will be censored on the date the patient was last known to be alive. | Cycle 1 Day 1 to date of death, assessed up to 57 months |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale | EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI) | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Baseline (Day 0), Months 5, 10 and EOT |
| Population PK (POPPK) and Exposure-Response (ER) Analysis of Rociletinib | Sparse blood sampling for POPPK and ER analyses in all patients treated with rociletinib. | Every 4 weeks for approximately 6 months (Day 1 of Cycles 2 to 7 inclusive) |
| Bakersfield |
| California |
| 93309 |
| United States |
| Saint Jude Heritage Healthcare | Fullerton | California | 92835 | United States |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Northridge Hospital Medical Center | Northridge | California | 91328 | United States |
| Cancer Care Associates | Redondo Beach | California | 90277 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| University of California San Francisco | San Francisco | California | 94115 | United States |
| Coastal Integrative Cancer Care | San Luis Obispo | California | 93401 | United States |
| Saint Mary's Regional Cancer Center | Grand Junction | Colorado | 81501-6132 | United States |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | 80218 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 32135 | United States |
| Advanced Medical Specialties | Miami | Florida | 33176 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | United States |
| Beth Israel Comprehensive Cancer Center | Boston | Massachusetts | 02215 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Minnesota Oncology Hematology, P.A | Minneapolis | Minnesota | 55404 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| New York Oncology Hematology, PC | Latham | New York | 12110-2188 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| Texas Oncology P.A. | Amarillo | Texas | 79106 | United States |
| USO - Texas Oncology P.A. | Arlington | Texas | 76014 | United States |
| Texas Oncology-Austin Central | Austin | Texas | 78705 | United States |
| Texas Oncology-Beaumont | Beaumont | Texas | 77702 | United States |
| Texas Oncology P.A. | Bedford | Texas | 76022 | United States |
| Texas Oncology P.A. | Dallas | Texas | 75246 | United States |
| Texas Oncology P.A. | Flower Mound | Texas | 75028 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Texas Oncology - Plano East | Plano | Texas | 75075-7787 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98686 | United States |
| Yakima Valley Memorial Hospital, North Star Lodge | Yakima | Washington | 98902 | United States |
| Icon Cancer Centre | South Brisbane | New South Wales | 4101 | Australia |
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2L7 | Canada |
| Centre Hospitalier Lyon Sud | Pierre Bénité Cedex | Auvergne-Rhône-Alpes | 69495 | France |
| Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz | Besançon | Franche-comte | 25030 cedex | France |
| Institut de Cancérologie de l'Ouest - René Gauducheau | Saint-Herblain | Pays de la Loire Region | France |
| Centre Hospitalier Universitaire Côte de Nacre | Caen | France |
| Centre Hospitalier Universitaire Hôpital Nord | Marseille | 13915 | France |
| Hôpital Tenon | Paris | Île-de-France Region | 75020 | France |
| Institut Gustave Roussy | Villejuif | Île-de-France Region | 94805 | France |
| Asklepios Fachkliniken München-Gauting | Gauting | Bavaria | 82131 | Germany |
| Klinikum Innenstadt LMU | München | Bavaria | 80336 | Germany |
| Goethe-Universität Frankfurt am Main | Frankfurt am Main | Hesse | 60590 | Germany |
| Pius Hospital Oldenburg | Oldenburg | Lower Saxony | 26121 | Germany |
| Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Universitätsklinikum Köln | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitätsklinikum Essen | Essen | North Rhine-Westphalia | 45122 | Germany |
| LungenClinic Großhansdorf GmbH | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Evangelische Lungenklinik Berlin | Berlin | 13125 | Germany |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Antoni van Leeuwenhoek Hospital | Amsterdam | North Holland | 1066 CX | Netherlands |
| Vrije Universiteit Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| National Cancer Center | Goyang-si | Gyeonggi-do | South Korea |
| Gachon University Gil Medical Center | Incheon | Gyeonggi-do | 405-760 | South Korea |
| Chungbuk National University Hospital | Chungju | North Chungcheong | South Korea |
| Dong-A University Hospital | Busan | South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul Saint Mary's Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| Hospital Universitario Virgen del Rocio | Seville | Sevilla | 41013 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Spain |
| Hospital Vall d´Hebrón | Barcelona | 08035 | Spain |
| Hospital Universitario Quirón Dexeus | Barcelona | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Centre Hospitalier Universitaire Vaudoise | Lausanne | Canton of Vaud | 1011 | Switzerland |
| Taipei Veterans General Hospital | Taipei | Taipei CITY | 11217 | Taiwan |
| Chang Gung Memorial Hospital Linkou | Taoyuan | Tao-Yuan | 33305 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | CB2 0QQ | United Kingdom |
| Guy's and Saint Thomas NHS Foundation Trust | London | Greater London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | London | Greater London | SW3 6JJ | United Kingdom |
| Royal Marsden NHS Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| University College Hospital | London | NW1 2PQ | United Kingdom |
| FG002 | Rociletinib 500 mg BID T790M- | Rociletinib 500 mg BID in patients with T790M-negative tumor status |
| COMPLETED |
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| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rociletinib 625 mg BID T790M+ | Rociletinib 625 mg BID in patients with T790M-positive tumor status |
| BG001 | Rociletinib 500 mg BID T790M+ | Rociletinib 500 mg BID in patients with T790M-positive tumor status |
| BG002 | Rociletinib 500 mg BID T790M- | Rociletinib 500 mg BID in patients with T790M-negative tumor status |
| BG003 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| T790M Status | Count of Participants | 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 | Objective Response Rate (ORR) According to RECIST Version 1.1 as Determined by Investigator Assessment | ORR is defined as the percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is 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 the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Investigator Tumor Evaluable Population - defined as all patients who received at least 1 dose of rociletinib, have at least 1 measureable tumor lesion at baseline, and have at least 1 post-baseline tumor assessment as determined by the investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 1 Day 1 to End of Treatment, up to approximately 57 months. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment | DOR in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis. | Centrally-confirmed T790M-positive subset of the Investigator Tumor Evaluable Population - defined as all patients who received at least 1 dose of rociletinib, have at least 1 measureable tumor lesion at baseline, and have at least 1 post-baseline tumor assessment as determined by the investigator. | Posted | Median | 95% Confidence Interval | months | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 54 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) by RECIST v1.1 as Determined by Investigator Assessment | DCR is defined as the percentage of patients who have achieved CR, PR, and SD lasting at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is 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 the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. | Investigator Tumor Evaluable Population - defined as all patients who received at least 1 dose of rociletinib, have at least 1 measureable tumor lesion at baseline, and have at least 1 post-baseline tumor assessment as determined by the investigator. | Posted | Number | 95% Confidence Interval | percentage of patients | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in T790M Positive Patients by RECIST v1.1 as Determined by Investigator Assessment | PFS was calculated as 1+ the number of days from the first dose of study drug to documented radiographic progression or death due to any cause, whichever occurs first. Patients without a documented event of radiographic progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments were performed. For patients who continued treatment post-progression, the first date of progression was used for the analysis of PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter 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. The appearance of one or more new lesions is also considered progression. | Centrally-confirmed T790M-positive subset of the Intent-to-treat (ITT) population defined as all patients who received at least 1 dose of rociletinib. | Posted | Median | 95% Confidence Interval | months | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Determined by Investigator Assessment | OS was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death will be censored on the date the patient was last known to be alive. | Centrally-confirmed T790M-positive subset of the Intent-to-treat (ITT) population defined as all patients who received at least 1 dose of rociletinib. | Posted | Median | 95% Confidence Interval | months | Cycle 1 Day 1 to date of death, assessed up to 57 months |
|
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale | EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI) | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale | EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms. | Safety population - defined as all patients who received at least 1 dose of rociletinib. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Months 5, 10 and EOT |
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| Secondary | Population PK (POPPK) and Exposure-Response (ER) Analysis of Rociletinib | Sparse blood sampling for POPPK and ER analyses in all patients treated with rociletinib. | Population PK (PPK) and exposure-response (ER) analysis were listed as a secondary objective. These analyses were conducted based on pooled data from multiple rociletinib trials (including TIGER2), thus no PPK or ER report was generated specifically for this study. | Posted | Every 4 weeks for approximately 6 months (Day 1 of Cycles 2 to 7 inclusive) |
|
|
Adverse events were reported from the date of first dose of study drug and within 28 days after last dose of study drug, or up to approximately 62 months. In addition, study procedure-related AEs that occurred after signing of the informed consent form and before first dose of study drug were expected to be reported.
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 | Rociletinib 625 mg BID T790M+ | Rociletinib 625 mg BID in patients with T790M-positive tumor status | 27 | 154 | 77 | 154 | 153 | 154 |
| EG001 | Rociletinib 500 mg BID T790M+ | Rociletinib 500 mg BID in patients with T790M-positive tumor status | 7 | 100 | 48 | 100 | 100 | 100 |
| EG002 | Rociletinib 500 mg BID T790M- | Rociletinib 500 mg BID in patients with T790M-negative tumor status | 9 | 63 | 34 | 63 | 63 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angle closure glaucoma | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Biliary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Listeria sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bladder perforation | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cystitis interstitial | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thromobcytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Department | Clovis Oncology, Inc. | +1 415 409 7220 | medinfo@clovisoncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 12, 2015 | Jul 17, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
Not provided
Not provided
| ID | Term |
|---|---|
| C000589977 | rociletinib |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| T790M Positive |
|
| Missing |
|
All Rociletinib 500 mg BID and 625 mg BID patients with T790M-positive tumor status |
|
|
| OG002 | Rociletinib 500 mg BID T790M- | Rociletinib 500 mg BID in patients with T790M-negative tumor status |
|
|
Rociletinib 500 mg BID in patients with T790M-positive tumor status |
| OG002 | All T790M+ | All Rociletinib 500 mg BID and 625 mg BID patients with T790M-positive tumor status |
|
|
| Participants |
|
|
Rociletinib 500 mg BID in patients with T790M-negative tumor status |
|
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