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Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subjects (≥ 70 years old) with advanced NSCLC
This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: nab-Paclitaxel and Carboplatin (Every 21 days) | Other | nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of every 21-day treatment cycle |
|
| Arm B: nab-Paclitaxel and Carboplatin (Every 28 days) | Other | nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment followed by one-week break and Carboplatin AUC = 6 mg*min/mL IV following nab-paclitaxel infusion on Day 1 of each 21-day treatment followed by one-week break |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-paclitaxel | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values | Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm^3; anemia hemoglobain levels (Hgb) <8.0 - 6.5 g/dL; <4.9 - 4.0 mmol/L; <80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels <100,000 cells/mm^3. | From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events During the Treatment Period | Treatment-emergent adverse events (TEAEs) were defined as any AE or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. Any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the scale: Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death. |
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Inclusion Criteria: -
Inclusion Criteria: -
Age ≥ 70 years at the time of signing the Informed Consent Form.
Understand and voluntarily provide written informed consent prior to the conduct of any study related assessments/procedures.
Able to adhere to the study visit schedule and other protocol requirements.
Histologically or cytologically confirmed locally advanced or metastatic non small cell lung cancer who are not candidates for curative surgery or radiation therapy.
No other current active malignancy requiring anticancer therapy.
Radiographically documented measurable disease per RECIST v 1.1
No prior chemotherapy for the treatment of metastatic disease. Adjuvant chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12 months prior to signing the informed consent form (ICF) and without disease recurrence. Participans with previously known epidermal growth factor receptor mutation or anaplastic lymphoma kinase gene translocation must have failed or had intolerance to one treatment with epidermal growth factor receptor tyrosine kinase inhibitor or anaplastic lymphoma kinase inhibitor therapy, respectively.
Absolute neutrophil count ≥ 1500 cells/cubic millimetre.
Platelets ≥ 100,000 cells/cubic millimetre.
Hemoglobin ≥ 9 grams/decilitre.
Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal range or ≤ 5.0 × upper limit of normal range if liver metastases.
Total bilirubin ≤ 1.5 millilitre/decilitre (unless there is a known history of Gilberts Syndrome).
Creatinine clearance > 40 millilitre/minute calculated using Cockcroft-Gault equation (if renal impairment is suspected 24 hour urine collection for measurement is required).
Eastern Cooperative Oncology Group performance status 0 or 1.
Females who (1) have undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been naturally postmenopausal for at least 24 consecutive months (ie, has not had menses at any time during the preceding 24 consecutive months).
Male subjects must: Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.
Exclusion Criteria:
1. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.
2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable. 4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0).
5. Participant has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30% of the bone marrow was irradiated. Prior radiation therapy to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
6. Venous thromboembolism within 1 month prior to signing informed consent form.
7. Current congestive heart failure (New York Heart Association Class II-IV). 8. History of the following within 6 months prior to first administration of a study drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral artery bypass graft, New York Heart Association Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically significant Electrocardiogram abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder.
9. Participant has a known infection with hepatitis B or C, or history of human immunodeficiency virus infection, or participant is receiving immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications.
10. Participant has an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
12. Treatment with any investigational product within 28 days prior to signing the informed consent form.
13. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14. Currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices. 15. Any other clinically significant medical condition, psychiatric illness, and/or organ dysfunction that will interfere with the administration of the therapy according to this protocol or which, in the views of investigator, preclude combination chemotherapy.
16. Participant has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer Tumor, Lymph Node, Metastatic (TNM stage of T1a or T1b). All treatment of which should have been completed 6 months prior to signing Informed consent form.
17. Any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
18. Any medical condition that confounds the ability to interpret data from the study.
19. Females who (1) have not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months).
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| Name | Affiliation | Role |
|---|---|---|
| Teng Jin Ong | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | United States | ||
| Genesis Cancer Center |
Participants ≥ 70 years old were randomized 1:1 to nab-paclitaxel and carboplatin on a 21-day treatment regimen or nab-paclitaxel and carboplatin on a 28-day treatment regimen; participants were stratified by Eastern Cooperative Oncology Group performance status (0 versus 1) and histology (squamous cell carcinoma versus non-squamous cell carcinoma)
This multicenter study was conducted in the United States and enrolled participants at a total of 41 sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan: ABI-007-NSCL-005_SAP_AM!_Redacted.17March 2016 | Mar 17, 2016 |
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| Carboplatin | Drug |
|
| From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively. |
| Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn | The percentage of participants with at least 1 TEAE with action taken as studydrug withdrawn during the treatment period of the trial was assessed throughout the conduct of the study. Study drug withdrawn (treatment permanently discontinued) was attributed to the part in which the onset of the adverse event took place. | From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
| Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study | Dose intensity was the cumulative dose divided by the dosing period in weeks. | From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
| Dose Intensity Per Week of Carboplatin During the Entire Study | Dose intensity for carboplatin was the cumulative dose divided by the dosing period in weeks." | From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
| Percentage of Participants With Dose Reductions During the Entire Study | A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities. | From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
| Percentage of Participants With a Dose Delay During the Entire Study | A dose delay occurred when the dose assigned at a visit was held compared to the previous visit. Dose delays were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities. | From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 16 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
| Kaplan Meier Estimate of Progression-Free Survival (PFS) | Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir | From first dose of IP to the date of disease progression; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for PFS for 31 months and 20 months respectively |
| Kaplan Meier Estimate of Overall Survival (OS) | Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact. | From first dose of IP to the date of death due to any cause; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for OS for 31 months and 33 months respectively |
| Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 Criteria | Overall response rate (ORR) was defined as the percentage of participants who had radiologic CR or PR compared to baseline (radiographic evaluation on the day of or within 28 days prior to randomization) according to RECIST Version 1.1 criteria as determined by the investigator, which was confirmed by repeated radiologic assessment performed no less than 28 days after the criteria for response were first met and occurred between Day 1 of treatment and the start of subsequent anticancer therapy, death or study discontinuation. A complete response and partial response per RECIST V 1.0 criteria was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. | From the first dose of IP to the date of documented first response; up to the data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively. |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| Comprehensive Blood and Cancer Center | Bakersfield | California | 93309 | United States |
| Saint Jude Heritage Medical Center | Fullerton | California | 92835 | United States |
| Global Cancer Research Institute (GCRI), Inc. | Gilroy | California | 95020 | United States |
| Ventura County Hematology-Oncology Specialists | Oxnard | California | 93030 | United States |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| University of California Los Angeles | Santa Monica | California | 90404 | United States |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80218 | United States |
| St Mary's Hospital and Regional Medical Center | Grand Junction | Colorado | 81501 | United States |
| Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States |
| Baptist Cancer Inst | Jacksonville | Florida | 32207 | United States |
| Ocala Oncology Center | Ocala | Florida | 34471 | United States |
| Florida Hospital Cancer Institute | Orlando | Florida | 32804 | United States |
| Northshore University Healthsystem Research Institute | Evanston | Illinois | 60201 | United States |
| Oncology Specialists, S.C. | Niles | Illinois | 60714 | United States |
| Franciscan St. Francis Health | Indianapolis | Indiana | 46237 | United States |
| Cancer Center of Kansas | Wichita | Kansas | 67214 | United States |
| Western Kentucky Hematology and Oncology Group | Paducah | Kentucky | 42003 | United States |
| West Jeffersion Medical Center | Marrero | Louisiana | 70072 | United States |
| Ochsner Medical Institutions | New Orleans | Louisiana | 70123 | United States |
| Medstar Health Research Institute | Baltimore | Maryland | 21237 | United States |
| Reliant Medical Group | Worcester | Massachusetts | 01608 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202-268 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Center for Cancer and Hematologic Disease | Cherry Hill | New Jersey | 08003 | United States |
| Regional Cancer Care Associates LLC | East Brunswick | New Jersey | 08816 | United States |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Carol G Simon Cancer Center | Morristown | New Jersey | 07962 | United States |
| Somerset Hematology-Oncology Associates | Somerville | New Jersey | 08876 | United States |
| Regional Cancer Care Associates LLC- Sparta division | Sparta | New Jersey | 07871 | United States |
| Brookdale University Hospital and Medical Center | Brooklyn | New York | 11212 | United States |
| Broome Oncology, LLC | Johnson City | New York | 13790 | United States |
| Clinical Research Alliance | Lake Success | New York | 11042 | United States |
| SUNY Upstate Medical University Medicine Oncology | Syracuse | New York | 13215 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Lineberger Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Forsyth Memorial Hospital, Inc. | Winston-Salem | North Carolina | 27103 | United States |
| St Elizabeth Hospital | Youngstown | Ohio | 44501 | United States |
| Cancer Centres of Southwest Okahoma Research | Lawton | Oklahoma | 73505 | United States |
| Good Samaritan Hospital Corvalis | Corvallis | Oregon | 97330 | United States |
| Oregon Health and Science University | Portland | Oregon | 97210 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Medical College | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Texas Oncology, P.A.-Amarillo | Amarillo | Texas | 79106 | United States |
| Baylor University Medical Center at Dallas | Dallas | Texas | 75246 | United States |
| UTMB Galveston | Galveston | Texas | 77555-0565 | United States |
| Texas Oncology, PA - Longview | Longview | Texas | 75601 | United States |
| Virginia Mason Cancer Center | Seattle | Washington | 98101 | United States |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | United States |
| FG001 | Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
| Treated Population |
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| COMPLETED | Completed indicates participants with missing disposition data. |
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| NOT COMPLETED |
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| Follow-Up Period |
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Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
| BG001 | Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) | Participant ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8 and 15 followed by a one week break in each 28-day treatment cycle and carboplatin area under the curve (AUC) = 6 mg*min/mL IV on Day 1 of each treatment cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity) | Number | Participants |
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| Confirmed Histology | Count of Participants | Participants |
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| Stage of Disease at Enrollment | Disease stage means how big the tumor is and how far it has spread. Disease stages range from 0 (not spread) to IV (spread throughout the body). Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes; if the tumor has spread only to the lymph nodes on the same side of the chest where the cancer started, it is Stage IIIA; if the tumor has spread to the lymph nodes on the opposite side or above the collar bone, it is Stage IIIb. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver. | Count of Participants | Participants |
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| Number of Prior Systemic Anticancer Therapies for Non-Small Cell Lung Cancer (NSCLC) | Median | Full Range | Therapies |
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| Body Mass Index (BMI) | Body Mass Index = (Weight in kg) / (Height in m)^2. | 1 participant's disposition is missing | Mean | Standard Deviation | Kg/m^2 |
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| Number of Participants with Peripheral Neuropathy at Baseline | Physician assessment for grading of peripheral neuropathy in participants receiving chemotherapy according to National Cancer Institute Common Toxicity Criteria (NCICTC): Grade 1 = Asymptomatic: loss of deep tendon reflexes or paresthesia; Grade 2 = Moderate symptoms: limiting instrumental Activities of Daily Living (ADLs); Grade 3 = Severe symptoms: limiting self-care ADL; assistance device indicated; Grade 4 = Life-threatening consequences: urgent intervention indicated. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values | Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm^3; anemia hemoglobain levels (Hgb) <8.0 - 6.5 g/dL; <4.9 - 4.0 mmol/L; <80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels <100,000 cells/mm^3. | Treated Population included all participants who were randomized and received at least 1 dose of the study treatment. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events During the Treatment Period | Treatment-emergent adverse events (TEAEs) were defined as any AE or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. Any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the scale: Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death. | Safety population included all participants who were randomized and received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively. |
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| Secondary | Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn | The percentage of participants with at least 1 TEAE with action taken as studydrug withdrawn during the treatment period of the trial was assessed throughout the conduct of the study. Study drug withdrawn (treatment permanently discontinued) was attributed to the part in which the onset of the adverse event took place. | Safety Population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Number | Percentage of Participants | From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
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| Secondary | Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study | Dose intensity was the cumulative dose divided by the dosing period in weeks. | Treated Population included all randomized participants who received any study drug. | Posted | Mean | Standard Deviation | mg/m^2/week | From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
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| Secondary | Dose Intensity Per Week of Carboplatin During the Entire Study | Dose intensity for carboplatin was the cumulative dose divided by the dosing period in weeks." | Treated Population included all randomized participants who received any study drug. | Posted | Mean | Standard Deviation | mg*min/mL/week | From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
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| Secondary | Percentage of Participants With Dose Reductions During the Entire Study | A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities. | The treated population consisted of all participants who received at least 1 dose of investigational product. | Posted | Number | Percentage of Participants | From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
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| Secondary | Percentage of Participants With a Dose Delay During the Entire Study | A dose delay occurred when the dose assigned at a visit was held compared to the previous visit. Dose delays were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities. | The safety population consisted of all participants who received at least 1 dose of investigational product. | Posted | Number | Percentage of Participants | From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 16 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively |
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| Secondary | Kaplan Meier Estimate of Progression-Free Survival (PFS) | Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir | Intent to Treat Population all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed. | Posted | Median | 95% Confidence Interval | months | From first dose of IP to the date of disease progression; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for PFS for 31 months and 20 months respectively |
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| Secondary | Kaplan Meier Estimate of Overall Survival (OS) | Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact. | Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed. | Posted | Median | 95% Confidence Interval | months | From first dose of IP to the date of death due to any cause; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for OS for 31 months and 33 months respectively |
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| Secondary | Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 Criteria | Overall response rate (ORR) was defined as the percentage of participants who had radiologic CR or PR compared to baseline (radiographic evaluation on the day of or within 28 days prior to randomization) according to RECIST Version 1.1 criteria as determined by the investigator, which was confirmed by repeated radiologic assessment performed no less than 28 days after the criteria for response were first met and occurred between Day 1 of treatment and the start of subsequent anticancer therapy, death or study discontinuation. A complete response and partial response per RECIST V 1.0 criteria was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of diameters of target lesions from baseline. | Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose of IP to the date of documented first response; up to the data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively. |
|
TEAEs are reported up to 37 months; from Day 1 of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter being suspected of being related to IP; up data cut-off date of 14 July 2017.
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 | Arm A: Nab-Paclitaxel and Carboplatin (21-day Treatment Cylce) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day treatment cycle and carboplatin area under the curve (AUC) at 6 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. | 45 | 71 | 23 | 68 | 68 | 68 |
| EG001 | Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. | 46 | 72 | 32 | 70 | 69 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Serratia infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ninety days. Investigator must delete confidential information before submission or defer publication to permit patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain, Senior Manager | Celgene Corporation | 888-260-1599 | ClinicalTrialDisclosure@Celgene.com |
| Jul 13, 2018 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-005_PA1_Redacted.09April2014 | Apr 9, 2014 | Jul 13, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: ABI-007-NSCL-005.OriginalSAP.Redacted24 June2016 | Jun 24, 2016 | Jul 13, 2018 | SAP_002.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-005_PA2_Redacted.05 December 2014 | Dec 5, 2014 | Jul 13, 2018 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-005_PA3_Redacted.17 March 2016 | Mar 17, 2016 | Jul 13, 2018 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-005_Original_Redacted.06 March2014 | Mar 6, 2014 | Jul 13, 2018 | Prot_005.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002277 | Carcinoma |
| D002294 | Carcinoma, Squamous Cell |
| D000230 | Adenocarcinoma |
| D018287 | Carcinoma, Large Cell |
| D008175 | Lung Neoplasms |
| 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 |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D056831 | Coordination Complexes |
Not provided
Not provided
|
|
|
|
| 1 = Restricted in Physical Activity; Ambulatory |
|
|
| 2 = Ambulatory and Capable of All Self-care |
|
|
| 3 = Capable of Only Limited Self-care |
|
|
| 4 = Completely Disabled. |
|
|
|
|
|
|
|
| OG001 | Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
|
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|
|
|
|
|
|
|
|
|
|
| OG001 | Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
|
|
|
Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.
|
|
|
| OG001 | Arm B: Nab-Paclitaxel and Carboplatin (28-day Treatment Cycle) | Participants ≥ 70 years old received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1, 8, and 15 followed by a one-week break in each 28-day treatment cycle and carboplatin area under the curve of 6 mg*min/mL IV on Day 1 after completion of nab-paclitaxel infusion of each treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care. |
|
|
|