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| Name | Class |
|---|---|
| Achieve Life Sciences | INDUSTRY |
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This randomized phase II study will compare the efficacy and safety of the combination of carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated advanced non-squamous NSCLC.
Modern doublet chemotherapy improves survival in patients with advanced non-small cell lung cancer (NSCLC) compared with supportive care alone, with non-squamous NSCLC patients treated with platinum/pemetrexed living longer than patients treated with platinum/gemcitabine. Despite these advances, poor outcomes with advanced disease warrant exploration of novel drugs with unique mechanisms of action. Preclinical evidence in lung cancer models shows promising antitumor activity with OGX-427 in combination with platinum based therapy or pemetrexed. In this double-blind, placebo-controlled, Phase II study, pemetrexed and carboplatin plus OGX-427 followed by maintenance pemetrexed and OGX-427 will be compared with pemetrexed and carboplatin plus placebo followed by maintenance pemetrexed and placebo in patients with previously untreated advanced non-squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OGX-427 | Experimental | Three loading doses of OGX-427 at 600mg intravenously (IV) will be administered over 9 days. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. The Treatment Phase will be followed by a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle. |
|
| Placebo | Placebo Comparator | Three loading doses of placebo will be administered intravenously (IV) over 9 days. Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. The Treatment Phase will be followed by a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OGX-427 | Drug | Three loading doses of 600mg OGX-427 will be administered intravenously (IV) during a 9 day period. Then 600mg IV OGX-427 will be given weekly on Days 1, 8 and 15 of each 21 day cycle prior to the administration of pemetrexed (500mg/m^2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle for a maximum of four treatment cycles. Patients who respond to treatment or have stable disease will continue to receive 600 mg IV OGX-427 plus 500mg/m2 IV pemetrexed weekly until toxicity or disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-Free Survival | Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions. | Every 6 weeks for up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of OGX-427 Versus Placebo Participants With an Objective Response | Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in baseline of 30% or more of the diameter(s) of all target lesions. | Every 6 weeks for up to 24 months |
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Inclusion Criteria:
Histologic or cytologic diagnosis of advanced NSCLC, excluding squamous cell and small cell histology. Tumors with mixed NSCLC histologies are eligible, as long as the predominant histology is not squamous. If small-cell elements are present or not otherwise specified histologically, the patient is not eligible.
Metastatic disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0).
No prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for metastatic disease; previous adjuvant or neoadjuvant therapy for Stage I, II, or III disease is allowed as long as the interval from the end of treatment until disease progression was >12 months.
No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area. Other radiation therapy must be completed at least 2 weeks prior to study entry. Must have recovered from acute adverse effects prior to study entry.
At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Baseline laboratory values as follows:
Glomerular Filtration Rate (GFR) = (140-age) x (weight/kg) x (0.85 if female)/(72 x serum creatinine mg/dL)
Fertile male patients willing to use adequate contraceptive measures.
Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization.
Life expectancy ≥ 12 weeks.
Must be ≥18 years of age at the time of consent.
Willingness and ability to comply with trial and follow-up procedures.
Ability to understand the nature of this trial and give written informed consent.
Exclusion Criteria:
Known anaplastic lymphoma kinase (ALK) translocation and epidermal growth factor receptor (EGFR) "activating" mutations where first-line treatment with targeted tyrosine kinase inhibitor therapy is more appropriate.
Known central nervous system (CNS) disease other than neurologically stable, treated brain metastases defined as metastasis having no evidence of progression or hemorrhage after treatment and no ongoing requirements for corticosteroids, (e.g., dexamethasone) for at least 2 weeks.
Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥ Class 2:
Patients currently receiving therapeutic anticoagulation.
Pregnant or lactating women.
Any serious, active underlying medical condition that would impair the ability of the patient to receive study treatment, such as diabetes mellitus or infection.
Unable or unwilling to take folic acid or vitamin B12.
Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring current need for cancer therapy or at high risk of recurrence (>30%) during the study.
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| David R. Spigel, M.D. | SCRI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States | ||
| Florida Cancer Specialists-South |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19097774 | Background | Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026. | |
| 19433683 |
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Subjects were enrolled and randomized in a 1:1 ratio to receive a combination of pemetrexed and carboplatin plus either OGX-427 (apatorsen) or a placebo.
Between August 2013 and February 2015, a total of 155 patients (77 patients on the OGX-427 (apatorsen) arm and 78 patients on the placebo arm) were enrolled and randomized on the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OGX-427 | OGX-427: Three loading doses of OGX-427 at 600mg intravenously (IV) will be administered over 9 days. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression. |
| 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 | Nov 5, 2014 | May 22, 2018 |
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|
|
| Placebo | Drug | Three loading doses of placebo will be administered intravenously (IV) during a 9 day period. Then placebo (IV) will be given weekly on Days 1, 8 and 15 of each 21 day cycle prior to the administration of pemetrexed (500mg/m^2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle for a maximum of four treatment cycles. Patients who respond to treatment or have stable disease will continue to receive placebo (IV) plus 500mg/m2 IV pemetrexed weekly until toxicity or disease progression. |
|
| Median Overall Survival | Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive. | Every 6 weeks for up to 41 months |
| Number of Patients With a Treatment-Related Adverse Event as a Measure of Safety. | A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. | Weekly during each 21 days cycle and for 30 days after last dose for up to 29 Months |
| Fort Myers |
| Florida |
| 33916 |
| United States |
| Florida Hospital Cancer Insitute | Orlando | Florida | 32804 | United States |
| Florida Cancer Specialists-North | St. Petersburg | Florida | 33705 | United States |
| Baptist Hospital East | Louisville | Kentucky | 40207 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07932 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| South Carolina Oncology Associates | Columbia | South Carolina | 29210 | United States |
| Tennessee Oncology - Chattanooga | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Gronberg BH, Bremnes RM, Flotten O, Amundsen T, Brunsvig PF, Hjelde HH, Kaasa S, von Plessen C, Stornes F, Tollali T, Wammer F, Aasebo U, Sundstrom S. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jul 1;27(19):3217-24. doi: 10.1200/JCO.2008.20.9114. Epub 2009 May 11. |
| 18506025 | Background | Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U, Digumarti R, Zukin M, Lee JS, Mellemgaard A, Park K, Patil S, Rolski J, Goksel T, de Marinis F, Simms L, Sugarman KP, Gandara D. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008 Jul 20;26(21):3543-51. doi: 10.1200/JCO.2007.15.0375. Epub 2008 May 27. |
| 12860938 | Background | Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44. doi: 10.1200/JCO.2003.11.136. |
| 17510053 | Background | Wu R, Kausar H, Johnson P, Montoya-Durango DE, Merchant M, Rane MJ. Hsp27 regulates Akt activation and polymorphonuclear leukocyte apoptosis by scaffolding MK2 to Akt signal complex. J Biol Chem. 2007 Jul 27;282(30):21598-608. doi: 10.1074/jbc.M611316200. Epub 2007 May 17. |
| 17015449 | Background | Zheng C, Lin Z, Zhao ZJ, Yang Y, Niu H, Shen X. MAPK-activated protein kinase-2 (MK2)-mediated formation and phosphorylation-regulated dissociation of the signal complex consisting of p38, MK2, Akt, and Hsp27. J Biol Chem. 2006 Dec 1;281(48):37215-26. doi: 10.1074/jbc.M603622200. Epub 2006 Oct 2. |
| FG001 | Placebo | Placebo: Three loading doses of placebo will be administered intravenously (IV) over 9 days. Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients that were randomized to either OGX-427 or placebo
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OGX-427 | OGX-427: Three loading doses of OGX-427 at 600mg intravenously (IV) will be administered over 9 days. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression. |
| BG001 | Placebo | Placebo: Three loading doses of placebo will be administered intravenously (IV) over 9 days. Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression. |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Median Progression-Free Survival | Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions. | All patients who were randomized | Posted | Median | 95% Confidence Interval | months | Every 6 weeks for up to 24 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of OGX-427 Versus Placebo Participants With an Objective Response | Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in baseline of 30% or more of the diameter(s) of all target lesions. | All patients who were randomized. | Posted | Count of Participants | Participants | Every 6 weeks for up to 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | Median Overall Survival | Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive. | All patients who were randomized. | Posted | Median | 95% Confidence Interval | Months | Every 6 weeks for up to 41 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients With a Treatment-Related Adverse Event as a Measure of Safety. | A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. | Randomized patients who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Weekly during each 21 days cycle and for 30 days after last dose for up to 29 Months |
|
Weekly during each 21 days cycle and for 30 days after last dose for up to 29 Months
Any untoward medical occurrence in a participant regardless of the relationship with the study drug per the Investigator's assessment. Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All-Cause Mortality was assessed in all randomized participants, while Serious and Other (Not Including Serious) Adverse Events was only assessed in participants who received at least one dose of study 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 | OGX-427 | OGX-427: Three loading doses of OGX-427 at 600mg IV will be administered Days -9 to -1. Following the loading dose period, OGX-427 will be administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. OGX-427 will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of OGX-427 administered at 600mg IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression. | 56 | 77 | 35 | 74 | 72 | 74 |
| EG001 | Placebo | Placebo: Three loading doses of placebo will be administered IV Days -9 to -1. Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle during the Treatment Phase. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered. Patients with objective response or stable disease after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression. | 61 | 78 | 32 | 76 | 75 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Night sweats | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dry skin | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rash maculo-papular | Metabolism and nutrition disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.1) | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (17.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director, Regulatory Science | Sarah Cannon Development Innovations | 844-710-6157 | CANN.InnovationsMedical@sarahcannon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 21, 2015 | May 22, 2018 | 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 |
|---|---|
| C000595177 | apatorsen |
Not provided
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 |
|
|
|
|
|
Placebo: Three loading doses of placebo will be administered intravenously (IV) over 9 days.
Following the loading dose period, placebo will be administered IV weekly Days 1, 8 and 15 of each 21 day cycle. Placebo will be given prior to the administration of pemetrexed (500mg/m2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle. A maximum of four treatment cycles will be administered.
Patients without toxicity or disease progression after four cycles of therapy will move on to a Maintenance Phase of placebo administered IV weekly Days 1, 8 and 15 of each 21 day cycle plus pemetrexed (500mg/m2 IV on Day 1). Patients may remain on maintenance as long as they are benefiting and have no evidence of disease progression.
|
|