Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003804-66 | EudraCT Number |
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
Maintenance treatment of advanced stage squamous cell NSCLC.
Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell NSCLC.
Subjects who discontinued treatment from the maintenance part for any reason other than withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that had a visit 28 days after progression or discontinuation.
Those who entered Follow-up without progression continued with follow-up scans according to standard of care (SOC) until documentation of progression of disease. Additionally, subjects were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up to approximately 5 years after the last subject was randomized.
The sponsor used 15 Sep 2017 as the database cut-off date.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abraxane + Best Supportive Care (BSC) | Experimental | Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes Abraxane plus best supportive care. |
|
| Best Supportive Care (BSC) | Other | Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes best supportive care only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abraxane (Induction) | Drug | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance | Progression-free survival is defined as the time in months from the date of randomization 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 computerized axial tomography [CT scan], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions. | From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance | Overall survival was defined as the duration in months between randomization 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 (01 August 2019 whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive. |
Not provided
Inclusion Criteria:
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 squamous cell Non Small Cell Lung Cancer at study entry.
No other current active malignancy requiring anticancer therapy.
Radiographically documented measurable disease at study entry (as defined by the Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria).
No prior chemotherapy for the treatment of metastatic disease at study entry. Adjuvant chemotherapy is permitted providing cytotoxic chemotherapy was completed 12 months prior to starting the study and without disease recurrence.
Absolute neutrophil count ≥ 1500 cells/mm^3.
Platelets ≥ 100,000 cells/mm^3.
Hemoglobin ≥ 9 g/dL.
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 × upper limit of normal range except in cases of Gilbert's disease and liver metastases.
Creatinine ≤ 1.5 mg/dL.
Expected survival of > 12 weeks for the Induction part of the study.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
For Maintenance part of the study, subjects must have received at least one dose of nab-paclitaxel in each of the 4 cycles during Induction
Pregnancy
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 (i.e., has had menses at any time during the preceding 24 consecutive months)] must:
Male subjects must:
c. agree to complete abstinence from heterosexual contact or use a condom during sexual contact with a female of child bearing potential while receiving study medication and within 6 months after last dose of study medication, even if he has undergone a successful vasectomy.
Females must abstain from breastfeeding during study participation and 3 months after IP discontinuation.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment into the Induction and Maintenance parts of the study (except if specified at study entry only):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teng Jin Ong, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clearview Cancer Institute Oncology Specialties, P.C | Huntsville | Alabama | 35805 | United States | ||
| Palo Verde Hematology Oncology, Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29138610 | Background | Thomas M, Spigel DR, Jotte RM, McCleod M, Socinski MA, Page RD, Gressot L, Knoble J, Juan O, Morgensztern D, Isla D, Kim ES, West H, Ko A, Ong TJ, Trunova N, Gridelli C. nab-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy. Lung Cancer (Auckl). 2017 Oct 30;8:207-216. doi: 10.2147/LCTT.S138570. eCollection 2017. | |
| 29089791 |
Not provided
Not provided
Participants with a response or stable disease during Induction were randomised 2:1 into investigative treatment (nab-paclitaxel plus best supportive care [BSC] or BSC only) stratified by disease stage, response during induction and Eastern Cooperative Oncology Group (ECOG) performance status.
The study was conducted at 87 sites in Germany, Italy, Spain, the United Kingdom and the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants - Induction | During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction |
|
Not provided
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 | May 19, 2017 | Sep 12, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Carboplatin (Induction) | Drug | 6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion |
|
| Abraxane (Maintenance) | Drug | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care |
|
| Best Supportive Care (Maintenance) | Other | The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents |
|
| Abraxane (Induction) | Drug | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care |
|
|
| Carboplatin (Induction) | Drug | 6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care |
|
| Best Supportive Care (Maintenance) | Other | The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents |
|
| From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months |
| Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study | Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. | Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study |
| Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study | PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to 01 August 2019, whichever occurred earlier. RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of new lesions is also considered progression. | Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study |
| Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study | Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause. Subjects who were alive at the time of analysis had their OS censored at the date or last contact of 01 August 2019, whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive. | Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months |
| Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction | Overall response in the maintenance period was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days. Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance. The 95% CI was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. - Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. | For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks. |
| Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study | Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for >= 6 weeks according to RECIST 1.1 criteria as determined by the investigator. Only participants with a confirmed CR/PR are included in this summary. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The 95% CI was calculated using Clopper-Pearson method. | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study |
| Time to Confirmed Response During Induction and Over the Entire Study | Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. Only participants with a confirmed CR or PR are included in this summary. | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study |
| Kaplan-Meier Estimate for Duration of Response Over the Entire Study | Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented. Participants who did not have PD after the response were censored on the date of last tumor assessment. If a participant died before PD, the participant was censored on the date of death. | Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study. |
| Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period | TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator. | Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance) |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study | TEAE over entire study is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and before the treatment discontinuation date plus 28 days, or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator. | From Day 1 up to 01 August 2019; (maximum treatment length plus 28 days); the maximum treatment duration was 234.1 weeks for entire study |
| Glendale |
| Arizona |
| 85304 |
| United States |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | United States |
| Genesis Cancer Center | Hot Springs | Arkansas | 71913 | United States |
| City of Hope Cancer Center | Duarte | California | 91010-3000 | United States |
| Cancer Care Associates of Fresno Medical Group Inc | Fresno | California | 93720 | United States |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Clinical Trials and Research Associates | Montebello | California | 90640 | United States |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80218 | United States |
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States |
| Lynn Cancer Institute | Boca Raton | Florida | 33486 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Watson Clinic, LLP Center for Cancer Care and Research | Lakeland | Florida | 33805 | United States |
| University of Miami Miller School of Medicine Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Ocala Oncology Center | Ocala | Florida | 34474 | United States |
| Orlando Health, Inc | Orlando | Florida | 32806 | United States |
| Memorial Cancer Institute West | Pembroke Pines | Florida | 33028 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| University Cancer and Blood Center, LLC | Athens | Georgia | 30607 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Joliet Oncology-Hematology Associates, Ltd. | Joliet | Illinois | 60435 | United States |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202-5149 | United States |
| Investigative Clinical Research of Indiana, LLC | Indianapolis | Indiana | 46260 | United States |
| Kansas University Medical Center | Westwood | Kansas | 66205 | United States |
| Cancer Center of Kansas (MAT) | Wichita | Kansas | 67208 | United States |
| Kentucky Cancer Clinic | Hazard | Kentucky | 41701 | United States |
| Norton Healthcare | Louisville | Kentucky | 40202 | United States |
| University of Louisville, J.G. Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute Louisville Oncology | Louisville | Kentucky | 40207 | United States |
| LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Maine Research Associates | Auburn | Maine | 04210 | United States |
| Eastern Maine Medical Center | Brewer | Maine | 04412 | United States |
| Center For Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Meritus Medical Center | Hagerstown | Maryland | 21742 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | United States |
| Western Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| St Joseph Oncology | Saint Joseph | Missouri | 64507 | United States |
| Mercy Medical Research Institute | Springfield | Missouri | 65804 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| Hematology-Oncology Associates of NNJ, P | Morristown | New Jersey | 07960 | United States |
| New York Oncology Hematology P.C. | Albany | New York | 12206 | United States |
| Clinical Research Alliance | Lake Success | New York | 11042 | United States |
| NYU Langone Medical Center | Lake Success | New York | 11042 | United States |
| Beth Israel Medical Centers | New York | New York | 10003 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Icahn School of Medicine at Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center Albert Einstein Cancer Center | The Bronx | New York | 10467 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534 | United States |
| Moses H. Cone Regional Cancer Center | Greensboro | North Carolina | 27403 | United States |
| Hematology and Oncology Associates, Inc. | Canton | Ohio | 44708 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| The Mark H. Zangmeister Center | Columbus | Ohio | 43219 | United States |
| Tri-County Hematology and Oncology Associates | Massillon | Ohio | 44646 | United States |
| Toledo Community Oncology Program | Toledo | Ohio | 43623 | United States |
| Mercy Clinic Oklahoma Communities, Inc. | Oklahoma City | Oklahoma | 73102 | United States |
| University of Oklahoma Peggy and Charles Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Erie Regional Cancer Center | Erie | Pennsylvania | 16505 | United States |
| Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania Health Systems | Philadelphia | Pennsylvania | 19104 | United States |
| Allegheny Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center - Cancer Pavilion | Pittsburgh | Pennsylvania | 15232 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| Chattanooga Oncology Hematology Care | Chattanooga | Tennessee | 37404 | United States |
| Associates in Oncology and Hematology | Chattanooga | Tennessee | 37421 | United States |
| Thompson Cancer Survival Center | Knoxville | Tennessee | 37916 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203-1632 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| TX Onc, PA- Beaumont | Beaumont | Texas | 77702-1449 | United States |
| Brooke Army Medical Center Francis Street Medical Center | Fort Sam Houston | Texas | 78235-8200 | United States |
| Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | United States |
| UT Health Oncology | Houston | Texas | 77030 | United States |
| Millenium Oncology | Houston | Texas | 77090 | United States |
| TX Onc Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Columbia Basin Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| St Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| West Virginia University, Berkeley Medical Center, Cancer and Infusion Center | Martinsburg | West Virginia | 25401 | United States |
| West Virginia University, Berkeley Medical Center, Cancer and Infusion Center | Morgantown | West Virginia | 26506 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Kliniken der Stadt Koln gGmbH - Krankenhaus Merheim | Cologne | 51109 | Germany |
| St. Antonius Hospital | Eschweiler | 52249 | Germany |
| Asklepios Fachkliniken Muenchen Gauting | Gauting | 82131 | Germany |
| Universitatsklinikum Halle Saale | Halle | 06120 | Germany |
| Diakoniekrankenhaus Halle | Halle | 6114 | Germany |
| Thorax Klinik | Heidelberg | 69126 | Germany |
| Universitat Des Saarlandes | Homburg | 66421 | Germany |
| Lungenklinik Lostau gGmbH | Lostau | 39291 | Germany |
| Klinik Loewenstein gGmbH | Löwenstein | 74245 | Germany |
| Universitatsklinikum Ulm | Ulm | 89081 | Germany |
| Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati | Avellino | 83100 | Italy |
| Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi | Bologna | 40138 | Italy |
| Azienda Ospedaliera Istituti Ospitalieri di Cremona | Cremona | 23100 | Italy |
| Istituto Nazionale Per La Ricerca Sul Cancro | Genova | 16132 | Italy |
| Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Azienda Ospedaliera San Gerardo | Monza | 20900 | Italy |
| Istituto Nazionale Tumori Regina Elena di Roma | Roma | 00144 | Italy |
| Ospedale San Vincenzo Taormina | Taormina | 98039 | Italy |
| Intituto Catalán de OncologÃa de Girona | Girona | 17007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda, Madrid | 28222 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Churchhill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Royal Marsden Hospital | Sutton | SM2 5PT | United Kingdom |
| Mudad R, Patel MB, Margunato-Debay S, Garofalo D, Lal LS. Comparative effectiveness and safety of nab-paclitaxel plus carboplatin vs gemcitabine plus carboplatin in first-line treatment of advanced squamous cell non-small cell lung cancer in a US community oncology setting. Lung Cancer (Auckl). 2017 Oct 19;8:179-190. doi: 10.2147/LCTT.S139647. eCollection 2017. |
| 30149366 | Background | Reni M, Zanon S, Balzano G, Passoni P, Pircher C, Chiaravalli M, Fugazza C, Ceraulo D, Nicoletti R, Arcidiacono PG, Macchini M, Peretti U, Castoldi R, Doglioni C, Falconi M, Partelli S, Gianni L. A randomised phase 2 trial of nab-paclitaxel plus gemcitabine with or without capecitabine and cisplatin in locally advanced or borderline resectable pancreatic adenocarcinoma. Eur J Cancer. 2018 Oct;102:95-102. doi: 10.1016/j.ejca.2018.07.007. Epub 2018 Aug 24. |
| 29878040 | Background | Yardley DA, Coleman R, Conte P, Cortes J, Brufsky A, Shtivelband M, Young R, Bengala C, Ali H, Eakel J, Schneeweiss A, de la Cruz-Merino L, Wilks S, O'Shaughnessy J, Gluck S, Li H, Miller J, Barton D, Harbeck N; tnAcity investigators. nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial. Ann Oncol. 2018 Aug 1;29(8):1763-1770. doi: 10.1093/annonc/mdy201. |
| 30773308 | Background | Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14. |
| 30209750 | Background | Kim S, Signorovitch JE, Yang H, Patterson-Lomba O, Xiang CQ, Ung B, Parisi M, Marshall JL. Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States. Adv Ther. 2018 Oct;35(10):1564-1577. doi: 10.1007/s12325-018-0784-z. Epub 2018 Sep 12. |
| 30115475 | Background | Weiss J, Gilbert J, Deal AM, Weissler M, Hilliard C, Chera B, Murphy B, Hackman T, Liao JJ, Grilley Olson J, Hayes DN. Induction chemotherapy with carboplatin, nab-paclitaxel and cetuximab for at least N2b nodal status or surgically unresectable squamous cell carcinoma of the head and neck. Oral Oncol. 2018 Sep;84:46-51. doi: 10.1016/j.oraloncology.2018.06.028. Epub 2018 Jul 19. |
| 30180593 | Background | Li F, Zhang H, He M, Liao J, Chen N, Li Y, Zhou S, Palmisano M, Yu A, Pai MP, Yuan H, Sun D. Different Nanoformulations Alter the Tissue Distribution of Paclitaxel, Which Aligns with Reported Distinct Efficacy and Safety Profiles. Mol Pharm. 2018 Oct 1;15(10):4505-4516. doi: 10.1021/acs.molpharmaceut.8b00527. Epub 2018 Sep 21. |
| 30014884 | Background | Pelzer U, Wislocka L, Juhling A, Striefler J, Klein F, Roemmler-Zehrer J, Sinn M, Denecke T, Bahra M, Riess H. Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Eur J Cancer. 2018 Sep;100:85-93. doi: 10.1016/j.ejca.2018.06.001. Epub 2018 Jul 4. |
| 29770997 | Background | Metts JL, Alazraki AL, Clark D, Amankwah EK, Wasilewski-Masker KJ, George BA, Olson TA, Cash T. Gemcitabine/nab-paclitaxel for pediatric relapsed/refractory sarcomas. Pediatr Blood Cancer. 2018 Sep;65(9):e27246. doi: 10.1002/pbc.27246. Epub 2018 May 17. |
| 30087851 | Background | Langer CJ, Kim ES, Anderson EC, Jotte RM, Modiano M, Haggstrom DE, Socoteanu MP, Smith DA, Dakhil C, Konduri K, Berry T, Ong TJ, Sanford A, Amiri K, Goldman JW, Weiss J; ABOUND.70+ Investigators. nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.70+ Study in Elderly Patients With Advanced NSCLC. Front Oncol. 2018 Jul 24;8:262. doi: 10.3389/fonc.2018.00262. eCollection 2018. |
| 30087850 | Background | Gajra A, Karim NA, Mulford DA, Villaruz LC, Matrana MR, Ali HY, Santos ES, Berry T, Ong TJ, Sanford A, Amiri K, Spigel DR. nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.PS2 Study in Patients With NSCLC and a Performance Status of 2. Front Oncol. 2018 Jul 24;8:253. doi: 10.3389/fonc.2018.00253. eCollection 2018. |
| 29946913 | Background | Cartwright TH, Parisi M, Espirito JL, Wilson TW, Pelletier C, Patel M, Babiker HM. Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting. Drugs Real World Outcomes. 2018 Sep;5(3):149-159. doi: 10.1007/s40801-018-0137-x. |
| 29936064 | Background | Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcon S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21. |
| 29932294 | Background | Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22. |
| 29658592 | Background | Topcul M, Ceti N IL, Ozbas Turan S, Kolusayin Ozar MO. In vitro cytotoxic effect of PARP inhibitor alone and in combination with nab-paclitaxel on triple-negative and luminal A breast cancer cells. Oncol Rep. 2018 Jul;40(1):527-535. doi: 10.3892/or.2018.6364. Epub 2018 Apr 12. |
| 30243879 | Background | Neumann CCM, von Horschelmann E, Reutzel-Selke A, Seidel E, Sauer IM, Pratschke J, Bahra M, Schmuck RB. Tumor-stromal cross-talk modulating the therapeutic response in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2018 Oct;17(5):461-472. doi: 10.1016/j.hbpd.2018.09.004. Epub 2018 Sep 7. |
| 30442938 | Background | Veenstra VL, Damhofer H, Waasdorp C, van Rijssen LB, van de Vijver MJ, Dijk F, Wilmink HW, Besselink MG, Busch OR, Chang DK, Bailey PJ, Biankin AV, Kocher HM, Medema JP, Li JS, Jiang R, Pierce DW, van Laarhoven HWM, Bijlsma MF. ADAM12 is a circulating marker for stromal activation in pancreatic cancer and predicts response to chemotherapy. Oncogenesis. 2018 Nov 16;7(11):87. doi: 10.1038/s41389-018-0096-9. |
| 30383906 | Background | Morgensztern D, Cobo M, Ponce Aix S, Postmus PE, Lewanski CR, Bennouna J, Fischer JR, Juan-Vidal O, Stewart DJ, Fasola G, Ardizzoni A, Bhore R, Wolfsteiner M, Talbot DC, Jin Ong T, Govindan R, On Behalf Of The Abound L Investigators. ABOUND.2L+: A randomized phase 2 study of nanoparticle albumin-bound paclitaxel with or without CC-486 as second-line treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). Cancer. 2018 Dec 15;124(24):4667-4675. doi: 10.1002/cncr.31779. Epub 2018 Nov 1. |
| 30100104 | Background | Marschner N, Salat C, Soling U, Hansen R, Grebhardt S, Harde J, Nusch A, Potthoff K. Final Effectiveness and Safety Results of NABUCCO: Real-World Data From a Noninterventional, Prospective, Multicenter Study in 697 Patients With Metastatic Breast Cancer Treated With nab-Paclitaxel. Clin Breast Cancer. 2018 Dec;18(6):e1323-e1337. doi: 10.1016/j.clbc.2018.07.010. Epub 2018 Aug 10. |
| 30529902 | Background | Watson S, de la Fouchardiere C, Kim S, Cohen R, Bachet JB, Tournigand C, Ferraz JM, Lefevre M, Colin D, Svrcek M, Meurisse A, Louvet C. Oxaliplatin, 5-Fluorouracil and Nab-paclitaxel as perioperative regimen in patients with resectable gastric adenocarcinoma: A GERCOR phase II study (FOXAGAST). Eur J Cancer. 2019 Jan;107:46-52. doi: 10.1016/j.ejca.2018.11.006. Epub 2018 Dec 7. |
| 30519122 | Background | Li YF, Zhang C, Zhou S, He M, Zhang H, Chen N, Li F, Luan X, Pai M, Yuan H, Sun D, Li Y. Species difference in paclitaxel disposition correlated with poor pharmacological efficacy translation from mice to humans. Clin Pharmacol. 2018 Nov 8;10:165-174. doi: 10.2147/CPAA.S185449. eCollection 2018. |
| 30503309 | Background | Hurria A, Soto-Perez-de-Celis E, Blanchard S, Burhenn P, Yeon CH, Yuan Y, Li D, Katheria V, Waisman JR, Luu TH, Somlo G, Noonan AM, Lee T, Sudan N, Chung S, Rotter A, Arsenyan A, Levi A, Choi J, Rubalcava A, Morrison R, Mortimer JE. A Phase II Trial of Older Adults With Metastatic Breast Cancer Receiving nab-Paclitaxel: Melding the Fields of Geriatrics and Oncology. Clin Breast Cancer. 2019 Apr;19(2):89-96. doi: 10.1016/j.clbc.2018.10.002. Epub 2018 Oct 16. |
| 30497432 | Background | Fernandez A, Salgado M, Garcia A, Buxo E, Vera R, Adeva J, Jimenez-Fonseca P, Quintero G, Llorca C, Canabate M, Lopez LJ, Munoz A, Ramirez P, Gonzalez P, Lopez C, Reboredo M, Gallardo E, Sanchez-Canovas M, Gallego J, Guillen C, Ruiz-Miravet N, Navarro-Perez V, De la Camara J, Ales-Diaz I, Pazo-Cid RA, Carmona-Bayonas A. Prognostic factors for survival with nab-paclitaxel plus gemcitabine in metastatic pancreatic cancer in real-life practice: the ANICE-PaC study. BMC Cancer. 2018 Nov 29;18(1):1185. doi: 10.1186/s12885-018-5101-3. |
| 30166402 | Background | Awasthi N, Schwarz MA, Zhang C, Schwarz RE. Augmentation of Nab-Paclitaxel Chemotherapy Response by Mechanistically Diverse Antiangiogenic Agents in Preclinical Gastric Cancer Models. Mol Cancer Ther. 2018 Nov;17(11):2353-2364. doi: 10.1158/1535-7163.MCT-18-0489. Epub 2018 Aug 30. |
| 29846848 | Background | Nakao A, Uchino J, Igata F, On R, Ikeda T, Yatsugi H, Hirano R, Sasaki T, Tanimura K, Imabayashi T, Tamiya N, Kaneko Y, Yamada T, Nagata N, Watanabe K, Kishimoto J, Takayama K, Fujita M. Nab-paclitaxel maintenance therapy following carboplatin + nab-paclitaxel combination therapy in chemotherapy naive patients with advanced non-small cell lung cancer: multicenter, open-label, single-arm phase II trial. Invest New Drugs. 2018 Oct;36(5):903-910. doi: 10.1007/s10637-018-0617-6. Epub 2018 May 30. |
| 30623229 | Background | Cristea MC, Frankel P, Synold T, Rivkin S, Lim D, Chung V, Chao J, Wakabayashi M, Paz B, Han E, Lin P, Leong L, Hakim A, Carroll M, Prakash N, Dellinger T, Park M, Morgan RJ. A phase I trial of intraperitoneal nab-paclitaxel in the treatment of advanced malignancies primarily confined to the peritoneal cavity. Cancer Chemother Pharmacol. 2019 Mar;83(3):589-598. doi: 10.1007/s00280-019-03767-9. Epub 2019 Jan 8. |
| 30006989 | Background | Hegewisch-Becker S, Aldaoud A, Wolf T, Krammer-Steiner B, Linde H, Scheiner-Sparna R, Hamm D, Janicke M, Marschner N; TPK-Group (Tumour Registry Pancreatic Cancer). Results from the prospective German TPK clinical cohort study: Treatment algorithms and survival of 1,174 patients with locally advanced, inoperable, or metastatic pancreatic ductal adenocarcinoma. Int J Cancer. 2019 Mar 1;144(5):981-990. doi: 10.1002/ijc.31751. Epub 2018 Oct 3. |
| 30739019 | Background | Wang Z, Huang C, Yang JJ, Song Y, Cheng Y, Chen GY, Yan HH, Ben XS, Wang BC, Xu CR, Jiang BY, Zhou Q, Chen HJ, Wu YL. A randomised phase II clinical trial of nab-paclitaxel and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell lung carcinoma (C-TONG1002). Eur J Cancer. 2019 Mar;109:183-191. doi: 10.1016/j.ejca.2019.01.007. Epub 2019 Feb 7. |
| 30863113 | Background | Woo W, Carey ET, Choi M. Spotlight on liposomal irinotecan for metastatic pancreatic cancer: patient selection and perspectives. Onco Targets Ther. 2019 Feb 21;12:1455-1463. doi: 10.2147/OTT.S167590. eCollection 2019. |
| 30481287 | Background | Seiwert TY, Foster CC, Blair EA, Karrison TG, Agrawal N, Melotek JM, Portugal L, Brisson RJ, Dekker A, Kochanny S, Gooi Z, Lingen MW, Villaflor VM, Ginat DT, Haraf DJ, Vokes EE. OPTIMA: a phase II dose and volume de-escalation trial for human papillomavirus-positive oropharyngeal cancer. Ann Oncol. 2019 Feb 1;30(2):297-302. doi: 10.1093/annonc/mdy522. |
| 30881017 | Background | De Luca R, Profita G, Cicero G. Nab-paclitaxel in pretreated metastatic breast cancer: evaluation of activity, safety, and quality of life. Onco Targets Ther. 2019 Feb 26;12:1621-1627. doi: 10.2147/OTT.S191519. eCollection 2019. |
| 30933354 | Background | Morgensztern D, Ko A, O'Brien M, Ong TJ, Waqar SN, Socinski MA, Postmus PE, Bhore R. Association between depth of response and survival in patients with advanced-stage non-small cell lung cancer treated with first-line chemotherapy. Cancer. 2019 Jul 15;125(14):2394-2399. doi: 10.1002/cncr.32114. Epub 2019 Apr 1. |
| 31002261 | Background | Li F, Yuan H, Zhang H, He M, Liao J, Chen N, Li Y, Zhou S, Palmisano M, Yu A, Pai M, Sun D. Neonatal Fc Receptor (FcRn) Enhances Tissue Distribution and Prevents Excretion of nab-Paclitaxel. Mol Pharm. 2019 Jun 3;16(6):2385-2393. doi: 10.1021/acs.molpharmaceut.8b01314. Epub 2019 May 1. |
| 30768369 | Background | Sonbol MB, Ahn DH, Goldstein D, Okusaka T, Tabernero J, Macarulla T, Reni M, Li CP, O'Neil B, Van Cutsem E, Bekaii-Saab T. CanStem111P trial: a Phase III study of napabucasin plus nab-paclitaxel with gemcitabine. Future Oncol. 2019 Apr;15(12):1295-1302. doi: 10.2217/fon-2018-0903. Epub 2019 Feb 15. |
| FG001 | Nab-Paclitaxel + Best Supportive Care (BSC) | Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression. |
| FG002 | Best Supportive Care (BSC) | Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
| Received Study Drug |
|
| COMPLETED | Completed = participants who continued to maintenance period. |
|
| NOT COMPLETED |
|
|
| Maintenance |
|
|
| Survival Follow-up |
|
|
Induction includes participants who were enrolled and treated however, baseline characteristics (BLC) for non-randomised participants is not displayed. The total number represents the ITT population in the maintenance phase.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nab-Paclitaxel + Best Supportive Care (BSC) | Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression. |
| BG001 | Best Supportive Care (BSC) | Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Continuous age values in Total column represent the 202 participants in the Maintenance Period. Induction includes participants who were enrolled and treated however, baseline characteristics for non-randomised participants is not displayed. The total number represents the ITT population in the maintenance phase. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Induction includes participants who were enrolled and treated in the induction phase. Baseline characteristics are displayed only for participants randomised in the maintenance phase. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Sex: Female, Male | Induction includes participants who were enrolled and treated in the induction phase. Baseline characteristics are displayed only for participants randomised in the maintenance phase. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Induction includes participants who were enrolled and treated in the induction phase. Baseline characteristics are displayed only for participants randomized in the maintenance phase. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Induction includes participants who were enrolled and treated in the induction phase. Baseline characteristics are displayed only for participants randomized in the maintenance phase. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS assesses 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. Baseline characteristics are displayed only for participants randomized in the maintenance phase. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Overall Tumor Response at End of Induction | Tumor response to Induction part chemotherapy for stratification is the response assessed at the last computed tomography (CT) scan before randomization. Baseline characteristics are displayed only for participants randomized in the maintenance phase. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Confirmed Histology | The histology categories included those with a tumor histology of squamous versus non-squamous types. Baseline characteristics for non-randomized participants is not displayed. The total number represents the ITT population in the maintenance phase. | Count of Participants | Participants |
| |||||||||||||||
| Disease Stage at Enrollment | Disease stage = 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 (LN). Stage II: the cancer has spread to some LN near the original tumor. Stage III: the cancer has spread to nearby tissue or spread to far away LN. Stage IV: the cancer has spread to other organs such as lung, brain, or liver. BLC are displayed for participants randomized in the maintenance phase. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance | Progression-free survival is defined as the time in months from the date of randomization 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 computerized axial tomography [CT scan], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions. | Intent to treat (ITT) population of participants randomized to Maintenance. The ITT population in the Maintenance part included all randomized subjects regardless of whether the subject received any study drug or had any efficacy assessments collected. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of disease progression or death of any cause; up to data cut off date of 15 September 2017; up to 27.6 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance | Overall survival was defined as the duration in months between randomization 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 (01 August 2019 whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive. | Intent to Treat population of participants randomized to maintenance. | Posted | Median | 95% Confidence Interval | months | From the date of randomization to death from any cause; up to 01 August 2019; survival follow up was 55.89 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study | Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. | Intent to treat population of participants randomized to Maintenance | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 of treatment in the induction period and subsequent anticancer therapy, death or discontinuation up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study | PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to 01 August 2019, whichever occurred earlier. RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of new lesions is also considered progression. | Intent to treat population of participants randomized to Maintenance | Posted | Median | 95% Confidence Interval | months | Between Day 1 of the Induction Part through to the date of disease progression or death; up to 01 August 2019; the maximum treatment duration was 234.1 weeks for entire study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study | Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause. Subjects who were alive at the time of analysis had their OS censored at the date or last contact of 01 August 2019, whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive. | ITT population of participants randomized to Maintenance. | Posted | Median | 95% Confidence Interval | months | Between Day 1 of treatment in the Induction Part to death from any cause; up to 01 August 2019; survival follow up was 55.89 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction | Overall response in the maintenance period was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days. Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance. The 95% CI was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. - Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. | Intent to treat population of participants randomized to the maintenance period. | Posted | Number | 95% Confidence Interval | percentage of participants | For the induction period the maximum treatment was 19 weeks for the maintenance period the maximum treatment was 150 weeks. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study | Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for >= 6 weeks according to RECIST 1.1 criteria as determined by the investigator. Only participants with a confirmed CR/PR are included in this summary. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The 95% CI was calculated using Clopper-Pearson method. | Induction includes the ITT population of participants treated during Induction. Entire Study includes the entire experience of the ITT population of participants randomized to maintenance. | Posted | Number | 95% Confidence Interval | percentage of participants | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 induction through maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Confirmed Response During Induction and Over the Entire Study | Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. Only participants with a confirmed CR or PR are included in this summary. | Includes the ITT population of participants who had a response. Induction includes the ITT population of participants treated during Induction who had a response. Induction+Maintenance includes the ITT population of participants randomized to Maintenance who had a response. | Posted | Median | Full Range | months | Induction is from Day 1 to a maximum treatment time of 19 weeks; entire study from Day 1 Induction through Maintenance up to PD; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate for Duration of Response Over the Entire Study | Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented. Participants who did not have PD after the response were censored on the date of last tumor assessment. If a participant died before PD, the participant was censored on the date of death. | The ITT population of participants randomized to the maintenance period and had a confirmed partial or complete response. | Posted | Median | 95% Confidence Interval | months | Between Day 1 of the Induction Period through to the date of disease progression or death; up to 01 August 2019; maximum treatment duration was 234.1 weeks for entire study. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Period | TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator. | Safety population of participants treated during induction period. | Posted | Count of Participants | Participants | Day 1 of Induction up to Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study | TEAE over entire study is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and before the treatment discontinuation date plus 28 days, or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator. | Safety population of participants randomized into maintenance, inclusive of both the induction and maintenance periods. | Posted | Count of Participants | Participants | From Day 1 up to 01 August 2019; (maximum treatment length plus 28 days); the maximum treatment duration was 234.1 weeks for entire study |
|
All-Cause Mortality events are reported from the ITT population (participants who received at least 1 dose of study treatment regardless of whether they had efficacy assessments collected); up to date of 01 August 2019.
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 | All Participants - Induction | During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had radiological or clinical progressive disease (PD), they were discontinued from the study and not followed. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she were eligible to be randomised to the maintenance phase | 80 | 420 | 177 | 420 | 417 | 420 |
| EG001 | Nab-Paclitaxel + Best Supportive Care (Maintenance) | Maintenance Phase: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression. | 82 | 130 | 32 | 130 | 122 | 130 |
| EG002 | Best Supportive Care (Maintenance) | Maintenance Phase: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. | 48 | 62 | 13 | 62 | 45 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pericardial haemorrhage | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Mouth haemorrhage | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pancreatitis relapsing | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Paraspinal abscess | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Aspiration bronchial | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V21.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA V21.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA V21.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA V21.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA V21.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V21.0 | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 1 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 90 additional days. Investigator must delete confidential information before submission and 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-003_protocol_AM1_Redacted 28 October 2014 | Oct 28, 2014 | Sep 12, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-003_protocol_AM2_Redacted.27May2015 | May 7, 2015 | Sep 12, 2018 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-003_protocol_AM3_Redacted.13March2017 | Mar 13, 2017 | Sep 12, 2018 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: ABI-007-NSCL-003.OriginalProtocolRedacted.27September2013 | Sep 27, 2013 | Sep 12, 2018 | Prot_004.pdf |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| D020360 | Neoadjuvant Therapy |
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| D008283 | Maintenance |
| 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 |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D056831 | Coordination Complexes |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
| Progressive disease |
|
| Symptomatic deterioration |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Other |
|
| >=65 years |
|
| <70 years |
|
| >=70 years |
|
| <75 years |
|
| >=75 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
| 1=fully ambulatory; restricted strenuous activity |
|
| >=2=ambulatory/self care; no work or worse |
|
| Partial response |
|
| Stable disease |
|
| Progressive disease |
|
| Not evaluable |
|
| Squamous cell carcinoma not confirmed |
|
| Stage IV |
|
| Superiority |
| Units | Counts |
|---|
| Participants |
|
|
|
| OG001 | BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
|
| OG001 | BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
|
| BSC: Induction + Maintenance |
Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
|
| OG001 | BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
|
| OG001 | Nab-Paclitaxel + BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression. |
| OG002 | BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
|
| OG001 | Nab-Paclitaxel + BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, plus best supportive care until disease progression. |
| OG002 | BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
| OG001 |
| BSC: Induction + Maintenance |
Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care: nab-paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle and carboplatin AUC = 6 mg*min/mL IV on Day 1 of each 21-day cycle. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
|
|
|
| OG001 | TEAE Specific to Nab-Paclitaxel | TEAE categories specific to nab-paclitaxel intervention as determined by the investigator. |
| OG002 | TEAE Specific to Carboplatin | TEAE categories specific to carboplatin intervention as determined by the investigator. |
|
|
| OG001 | Nab-Paclitaxel + BSC: TEAE Specific to Nab-Paclitaxel | TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. Nab-paclitaxel was administered during Induction and Maintenance. |
| OG002 | Nab-Paclitaxel + BSC: TEAE Specific to Carboplatin | TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. Carboplatin was administered during Induction. |
| OG003 | Nab-Paclitaxel + BSC: TEAE Specific to BSC | TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the Nab-Paclitaxel + BSC treatment arm. BSC was administered during Maintenance. |
| OG004 | BSC: Induction + Maintenance | Participants randomized to this treatment arm for Maintenance, inclusive of their experience during Induction. During induction, participants received nab-paclitaxel plus carboplatin as standard of care. If the participant had a complete response, partial response, or stable disease without PD at the end of 4 cycles, he/she continued to the maintenance phase. Maintenance: Following randomization, participants in this treatment arm were administered best supportive care (only) until disease progression. |
| OG005 | BSC: TEAE Specific to Nab-Paclitaxel | TEAE categories specific to nab-paclitaxel intervention, as determined by the investigator, for participants randomized to the BSC treatment arm. Nab-paclitaxel was administered during Induction. |
| OG006 | BSC: TEAE Specific to Carboplatin | TEAE categories specific to carboplatin intervention as determined by the investigator, for participants randomized to the BSC treatment arm. Carboplatin was administered during Induction. |
| OG007 | BSC: TEAE Specific to BSC | TEAE categories specific to best supportive care (BSC) as determined by the investigator, for participants randomized to the BSC treatment arm. BSC was administered during Maintenance. |
|
|