Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
4 cycles of induction treatment with nab-paclitaxel and carboplatin followed by nab-paclitaxel monotherapy for those subjects who are progression free at the end of 4 cycles.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nab-Paclitaxel | Experimental | nab-Paclitaxel 100 mg/m2 intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle • Carboplatin AUC = 5 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nab-Paclitaxel | Drug |
|
| |
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs). | Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, 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. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method. | From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate) | Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period | From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Protocol Dose | The percentage of protocol specified dose administered during the induction and monotherapy periods. Percentage of protocol dose = (dose intensity / protocol weekly dose) * 100%; the protocol weekly dose of nab-paclitaxel is 66.67 mg/m2/week; the protocol weekly dose of carboplatin was 1.67 mg*min/mL/week. | From Day 1 of study drug treatment to end of study drug treatment; up to clinical data cut-off date of 24 February 2017; ; maximum treatment duration was 14.1 months. |
Inclusion Criteria:
General and Demographics
Age ≥ 18 years of age at the time of signing the Informed Consent Form.
Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures.
Able to adhere to the study visit schedule and other protocol requirements. Disease Specific
Histologically or cytologically confirmed Stage IIIB or IV Non-Small Cell Lung Cancer.
Radiographically documented measurable disease at study entry per response evaluation criteria in solid tumours ( RECIST) v1.1.
No prior anti-cancer therapy for the treatment of metastatic disease at the time of signing the ICF. Adjuvant treatment is permitted providing cytotoxic chemotherapy was completed 12 months prior to signing the ICF and without disease recurrence.
Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.
Platelets ≥ 100,000 cells/mm3.
Hemoglobin (Hgb) ≥ 9 g/dL.
Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase [SGOT]), alanine transaminase (ALT/serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × upper limit of normal range (ULN) or ≤ 5.0 × ULN if liver metastases.
Total bilirubin ≤ 1.5 × ULN except in cases of Gilbert's disease and liver metastases.
Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 40 mL/min (if renal impairment is suspected 24-hour urine collection for measurement is required).
Eastern Cooperative Oncology Group Performance Status 2.
Females of childbearing potential [defined as a sexually mature woman 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)] must:
Have a negative pregnancy test Beta Human Chorionic Gonaditrophin(ß-hCG) as verified by the study doctor within 72 hours prior to starting study therapy.
You must commit to complete abstinence from heterosexual contact, or agree to use medical doctor-approved contraception throughout the study without interruption; while receiving study medication or for a longer period if required by local regulations.
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 at least 6 months following study drug discontinuation, even if he has undergone a successful vasectomy.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francois Lafleur, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Cancer Institute | Boynton Beach | Florida | 33426 | United States | ||
| Ochsner Clinic Nephrology |
Included participants with confirmed Stage IIIB or IV non-small cell lung cancer and measurable disease at study entry per Response Evaluation Criteria in Solid Tumors Version 1.1 with an Eastern Cooperative Oncology Group Performance Status of 2 and no prior anticancer therapy for the treatment of metastatic disease.
This multicenter study was conducted in the United States (US) and enrolled participants at 7 sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nab-Paclitaxel and Carboplatin | During the induction period, participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. In the absence of clinical or radiological disease progression, participants received monotherapy with nab-paclitaxel 100 mg/m^2 by intravenous infusion on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Period |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2017 | Feb 21, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Dose Intensity of Nab-Paclitaxel During the Entire Study | Dose intensity for nab-paclitaxel during the entire study period was (mg/m^2/week) = [cumulative dose for nab-paclitaxel in mg/m^2] / [nab-paclitaxel dosing period in weeks] | From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months |
| Dose Intensity of Carboplatin During the Entire Study | Dose intensity for carboplatin during the entire study period was (mg*min/mL/week) = [cumulative dose for carboplatin in mg*min/mL] / [carboplatin dosing period in weeks]. | From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months |
| Percentage of Participants With Dose Reductions During the Entire Study | A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities. | From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study |
| 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 Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate) | Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir | Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| 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 Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines | Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment. | Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| Time to Response | Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline | From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| Kaplan Meier Estimate of Duration of Response | Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method. | From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| Number of Participants With TEAEs During the Induction and Monotherapy Periods | Treatment-emergent adverse events were defined as any adverse event or serious adverse event 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. In addition, 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 were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. | From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months |
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| University of RochesterJames P. Wilmont Cancer Center | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Treated Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Monotherapy Period |
|
|
The treated population consisted of all participants who received at least 1 dose of investigational product (IP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | (Induction Period) Nab-Paclitaxel and Carboplatin | Participants received 4 cycles of nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle and carboplatin area under the curve (AUC) = 5 mg*min/mL IV on Day 1 of each 21-day cycle for 4 cycles. Participants could begin monotherapy with nab-paclitaxel in the absence of clinical or radiological disease progression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated population included all participants who received at least one dose of any study drug. | Mean | Standard Deviation | Years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | The Treated population consisted of all participants who received at least 1 dose of Investigational Product. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Race | Count of Participants | Participants |
| |||||||||||||||||||||||
| Physician Reported Eastern Cooperative Oncology Group (ECOG) Performance Status at Screening | 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) | The Treated population consisted of all participants who received at least 1 dose of Investigational Product. | Count of Participants | Participants |
| |||||||||||||||||||||
| Histology | Count of Participants | Participants |
| |||||||||||||||||||||||
| 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 0 - the cancer has not spread beyond the inner lining of the lung Stage I - the cancer is small and hasn't spread to the lymph nodes Stage II - the cancer has spread to some lymph nodes near the original tumor Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver. | Count of Participants | Participants |
| ||||||||||||||||||||||
| Number of Participants with Prior Systemic Anticancer Therapies | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs). | Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, 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. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method. | The Treated population consisted of all participants who received at least 1 dose of Investigational Product. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate) | Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period | The Treated population consisted of all participants who received at least 1 dose of Investigational Product. | Posted | Number | Percentage of Participants | From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months |
|
| |||||||||||||||||||||||||||
| Secondary | Dose Intensity of Nab-Paclitaxel During the Entire Study | Dose intensity for nab-paclitaxel during the entire study period was (mg/m^2/week) = [cumulative dose for nab-paclitaxel in mg/m^2] / [nab-paclitaxel dosing period in weeks] | The treated population consisted of all participants who received at least 1 dose of Investigational Product. | Posted | Mean | Standard Deviation | mg/m^2/week | From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months |
|
| ||||||||||||||||||||||||||
| Secondary | Dose Intensity of Carboplatin During the Entire Study | Dose intensity for carboplatin during the entire study period was (mg*min/mL/week) = [cumulative dose for carboplatin in mg*min/mL] / [carboplatin dosing period in weeks]. | The treated population consisted of all participants who received at least 1 dose of investigational Product. | Posted | Mean | Standard Deviation | mg*min/mL/week | From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Dose Reductions During the Entire Study | A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities. | The treated population consisted of all participants who received at least 1 dose of Investigational Product. | Posted | Number | Percentage of Participants | From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study |
|
| |||||||||||||||||||||||||||
| 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 | The treated Population consisted of all participants who received at least 1 dose of investigational product. | Posted | Median | 95% Confidence Interval | months | From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate) | Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir | The Treated population consisted of all participants who received at least 1 dose of IP | Posted | Number | 95% Confidence Interval | Percentage of Participants | Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| |||||||||||||||||||||||||||
| 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. | The Treated population consisted of all participants who received at least 1 dose of Investigational Product. | Posted | Median | 95% Confidence Interval | months | From Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines | Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment. | Participants who achieved a partial or complete response. | Posted | Number | 95% Confidence Interval | Percentage of participants | Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Response | Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline | Treated Population; participants with a CR or PR | Posted | Median | Full Range | Months | From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
|
| ||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate of Duration of Response | Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method. | Participants in the Treated population with a CR or PR. Participants who were non-responders (i.e., did not achieve at least a PR) were excluded from this analysis. | Posted | Median | Full Range | Months | From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs During the Induction and Monotherapy Periods | Treatment-emergent adverse events were defined as any adverse event or serious adverse event 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. In addition, 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 were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. | The Treated Population consisted of all participants who received at least 1 dose of IP. | Posted | Count of Participants | Participants | From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months |
| ||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Protocol Dose | The percentage of protocol specified dose administered during the induction and monotherapy periods. Percentage of protocol dose = (dose intensity / protocol weekly dose) * 100%; the protocol weekly dose of nab-paclitaxel is 66.67 mg/m2/week; the protocol weekly dose of carboplatin was 1.67 mg*min/mL/week. | The Treated Population consisted of all participants who received at least 1 dose of investigational product. | Posted | Median | Full Range | Percentage of Protocol Dose | From Day 1 of study drug treatment to end of study drug treatment; up to clinical data cut-off date of 24 February 2017; ; maximum treatment duration was 14.1 months. |
|
|
From date of first dose of IP until 28 days after the last dose of IP and those SAEs made known to the Investigator at any time thereafter that are suspected of being related to IP: up to the clinical cut-off date of 24 February 2017.
The maximum treatment duration was 14.1 months
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 | Induction: Nab-Paclitaxel/Carboplatin | Participant's received nab-paclitaxel 100 mg/m^2 intravenous infusion on Days 1 and 8 of each 21-day cycle and barboplatin AUC = 5 mg*min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion | 6 | 40 | 20 | 40 | 40 | 40 |
| EG001 | Monotherapy: Nab-Paclitaxel | Participants received nab-paclitaxel 100 mg/m^2 intravenous infusion on Days 1 and 8 of each 21-day cycle | 2 | 16 | 4 | 16 | 13 | 16 |
| EG002 | Follow-Up Period | Participants who discontinued IP for any reason other than lost to follow-up, entered into a follow-up period; scans were performed based on standard of care. Anti-cancer treatments were collected and participants were followed for survival every 90 days for up to 1 year. Death during follow-up is defined as any death that is more than 28 days post last dose of study drug | 16 | 31 | 0 | 31 | 0 | 31 |
| 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 |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | 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 |
| |
| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Local swelling | 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 |
| |
| Labyrinthitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
| |
| Sinusitis | 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 |
| |
| Fall | 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 |
| |
| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
| |
| Weight increased | 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 |
| |
| 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 |
| |
| Flank 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 |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system 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 |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast 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 |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Dyspnoea exertional | 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 |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
Due to slower than expected enrollment, Celgene elected to end enrollment. The decision was not based on safety concerns; those enrolled continued treatment and survival follow-up until 24 February 2017.
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 sixty days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ninety day and 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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-004ProtocolAm1RedactedFinal.12Jan 2015 | Jan 12, 2015 | Feb 21, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-004.OriginalProtocolRedacted11Aug2014 | Aug 11, 2014 | Feb 21, 2018 | Prot_002.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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
| Symptomatic Deterioration |
|
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| Miscellaneous |
|
|
| 2 = Ambulatory and Capable of All Self-care |
|
| 3 = Capable of Only Limited Self-care |
|
| 4 = Completely Disabled. |
|
| 5 = Dead |
|
| Title |
|---|
| Measurements |
|---|
|
| Stage II |
|
| Stage IIIb |
|
| Stage IV |
|
|
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|