Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001050-25 | EudraCT Number |
Not provided
Not provided
Not provided
An interim analysis was conducted in May-2014. Upon review of the data, the committee recommended study termination due to futility.
Not provided
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The purpose of this study was to determine if AUY922 had superior efficacy when compared to chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.
The primary purpose of this study was to compare the efficacy of AUY922, when administered i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed resistance to EGFR TKI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUY922 arm | Experimental | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly. |
|
| chemotherapy arm | Active Comparator | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUY922 | Drug | AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | 16 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time. |
Not provided
Inclusion Criteria:
Patients with histologically or cytologically documented, locally advanced (stage IIIB who are not amenable to combined modality treatment) or recurrent or metastatic (Stage IV) non-small cell lung cancer.
Patients must have EGFR gene mutation in their tumors. This can be source - documented by one of the following:
• Provide a pathology report that indicates the patient's tumor had EGFR activating mutation in the past.
Or:
• Perform testing (local or central) in an archival tumor or a fresh baseline biopsy tumor tissue to show the presence of EGFR activating mutation.
Patients must have documented clinical benefit (CR, PR, or patients with SD for 6 months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by documented progression according to RECIST.
Patients must have received prior platinum containing treatment.
WHO performance status of 0-1
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center Dept.of Cedars-Sinai Med. Ctr. | Los Angeles | California | 90048 | United States | ||
Not provided
Patients were randomized in a ratio of 1:1 to receive either AUY922 or pemetrexed/docetaxel. A total of 59 participants were randomized in the study: 31 to the AUY922 arm and 28 to the chemotherapy arm. 2 patients from the AUY922 arm & 5 from the chemotherapy arm were not treated. Only 52 received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AUY922 Arm | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly. |
| FG001 | Chemotherapy Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Docetaxel | Drug | Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity |
|
|
| Pemetrexed | Drug | Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity |
|
|
| 16 months |
| Overall Survival (OS) | OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive. | from randomization until death up to death |
| Disease Control Rate (DCR) | Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1 | baseline, until disease progression up to 24 months |
| Time to Response (TRR) | TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1 | baseline, until disease progression up to 24 months |
| Duration of Response (DOR) | The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1 | baseline, until disease progression up to 24 months |
| Rate of Adverse Events (AEs) | To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel. | baseline, until disease progression up to 24 months |
| Change in Laboratory Paramenters | Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity. | baseline, until disease progression up to 24 months |
| Time to Progression (TTP) | TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1 | baseline, until disease progression up to 24 months |
| Maryland Oncology Hematology, P.A. SC |
| Rockville |
| Maryland |
| 20850 |
| United States |
| University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 5 | Madison | Wisconsin | 53792-6164 | United States |
| Novartis Investigative Site | Marseille | Bouches Du Rhone | 13915 | France |
| Novartis Investigative Site | Créteil | 94000 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Hong Kong | Hong Kong |
| Novartis Investigative Site | Monza | MB | 20900 | Italy |
| Novartis Investigative Site | Milan | MI | 20133 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Koto Ku | Tokyo | 135 8550 | Japan |
| Novartis Investigative Site | Amsterdam | 1081 HV | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Bergen | 5021 | Norway |
| Novartis Investigative Site | Oslo | NO-0424 | Norway |
| Novartis Investigative Site | Gdansk | 80 952 | Poland |
| Novartis Investigative Site | Seoul | Korea | 05505 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06351 | South Korea |
| Novartis Investigative Site | Seoul | Seocho Gu | 06591 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Kuei-Shan Chiang | Taoyuan/ Taiwan ROC | 33305 | Taiwan |
| Novartis Investigative Site | Taichung | 407 | Taiwan |
| Novartis Investigative Site | Taipei | 10048 | Taiwan |
| Novartis Investigative Site | Leicester | LE1 5WW | United Kingdom |
Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.
Pemetrexed or docetaxel was to be was to be given once every three weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) comprised of all patients who were randomized to a study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AUY922 Arm | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly. |
| BG001 | Chemotherapy Arm | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions | Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment & an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped. | Posted | Median | 90% Confidence Interval | Months | 16 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time. | The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | Number | Participants | 16 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive. | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | from randomization until death up to death |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1 | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | baseline, until disease progression up to 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Response (TRR) | TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1 | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | baseline, until disease progression up to 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1 | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | baseline, until disease progression up to 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Adverse Events (AEs) | To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel. | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | baseline, until disease progression up to 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Laboratory Paramenters | Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity. | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | baseline, until disease progression up to 24 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1 | The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time. | Posted | baseline, until disease progression up to 24 months |
|
|
Not provided
Safety set: comprised of all participants who received at least one dose of study medication (AUY922, pemetrexed or docetaxel). In the safety set, patients were classified and analyzed according to the treatment received. Of the 59 participants randomized, only 52 received one dose of study medication.
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 | AUY922 Arm | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm. AUY922 was to be administered weekly. | 10 | 29 | 28 | 29 | ||
| EG001 | Chemotherapy Arm | Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm. Pemetrexed or docetaxel was to be was to be given once every three weeks. | 6 | 23 | 21 | 23 | ||
| EG002 | Total | Total | 16 | 52 | 49 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RETINAL DEGENERATION | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DISCOMFORT | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SUDDEN DEATH | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| METASTASES TO CENTRAL NERVOUS SYSTEM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ACCOMMODATION DISORDER | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NIGHT BLINDNESS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PHOTOPSIA | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VISUAL IMPAIRMENT | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| AXILLARY PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VISUAL FIELD DEFECT | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VISUAL PERSEVERATION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results to terminate the study early due to futility, data was not collected for this assessment on many of the secondary endpoints.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C528044 | 5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide |
| D000077143 | Docetaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
Not provided
Not provided
| Male |
|
| Units | Counts |
|---|---|
| Participants |
|
|