Carcinoma, Pancreatic Ductal
Conditions
Keywords
Neoplasms, Neoplasms by Site, Digestive System Neoplasms, Endocrine Gland Neoplasms, Pancreatic Neoplasms, Adenocarcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases, Albumin-Bound Paclitaxel, Gemcitabine
Brief summary
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult patients with Metastatic Pancreatic Ductal Adenocarcinoma.
Interventions
DRUGNapabucasin
Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.
DRUGNab-paclitaxel
Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
DRUGGemcitabine
Nab-paclitaxel 125 mg/m\^2 immediately followed by gemcitabine 1000 mg/m\^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written, signed consent for trial participation must be obtained from the patient appropriately in accordance with applicable International Conference on Harmonization (ICH) guidelines and local and regulatory requirements prior to the performance of any study specific procedure. 2. Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded. 3. Must not have previously received chemotherapy or any investigational agent for the treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed for as long as last dose was administered \> 6 months prior to randomization and no lingering toxicities are present. 4. Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended by the Investigator. 5. Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all sites of disease must be performed within 14 days prior to randomization. Qualifying scans performed as part of standard of care prior to patient signature of the study informed consent will be acceptable as baseline scanning as long as scanning is performed \< 14 days prior to randomization. 6. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true. 7. Must have life-expectancy of \> 12 weeks. 8. Must be ≥ 18 years of age. Due to increased risk of sepsis in patients \>80 years old, candidate patients in this age group should be thoroughly evaluated prior to study randomization to ensure they are fit to receive chemotherapy. In addition to all of the inclusion/
Exclusion criteria
listed, clinical judgment should be used regarding patients' susceptibility to infection (including but not limited to presence of ascites or diabetes mellitus increasing risk of infection). Furthermore, the expected stability of their performance status while receiving repeat weekly chemotherapy cycles should be given special attention. Patients in this age group should not be randomized on the study should there be any hesitation on any of these considerations. 9. For male or female patients of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female patients and for 90 days for male patients, after the final napabucasin dose if nab-paclitaxel and gemcitabine were not administered. 10. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 5 days prior to randomization. 11. Patient has adequate biological parameters as demonstrated by the following blood counts at baseline (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization): 1. Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L 2. Platelet count \> 100,000/mm\^3 (100 x 10\^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment. 3. Hemoglobin (HgB) \> 9 g/dL. Must not have required transfusion of red blood cells within 1 week of baseline Hgb assessment. 12. Patient has the following blood chemistry levels at baseline (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization): 1. AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) \[≤ 5 × ULN in presence of liver metastases\] 2. Total bilirubin ≤ 1.5 x institutional ULN. If total bilirubin is \> ULN and \< 1.5 x ULN, it must be non-rising for at least 7 days. 3. Serum creatinine within normal limits or calculated clearance \> 60 mL/min/1.73 m\^2 for patients with serum creatinine levels above or below the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For patients with a Body Mass Index (BMI) \> 30 kg/m\^2, lean body weight should be used instead. 13. Patient not on anticoagulation has acceptable coagulation studies (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization) as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or within normal limits (+15%). Patients on anticoagulation must have coagulation values within the therapeutic range appropriate for the anti-coagulation indication. 14. Patient has no clinically significant abnormalities on urinalysis results (obtained \< 14 days prior to randomization; laboratory testing performed as part of standard of care prior to patient signature of informed consent for the study will be acceptable as baseline laboratory work as long as testing is performed \< 14 days prior to randomization). 15. Patient must have adequate nutritional status with Body Mass Index (BMI) \> 18 kg/m\^2 and body weight of \> 40 kg with serum albumin \> 3 g/dL. 16. Baseline laboratory evaluations must be done within 14 days prior to randomization and some must be repeated \< 72 hours prior to randomization. 17. Patients requiring biliary stent placement must have biliary stent placed \> 7 days prior to screening. 18. Pain symptoms should be stable (of tolerable Grade 2 or less). 19. Only patients with available archival tumor tissue must consent to provision of, and Investigator(s) must confirm access to and agree to submit a representative formalin fixed paraffin block of tumor tissue in order that the specific correlative marker assays (Correlative Studies) of this protocol may be conducted. Submission of the tissue does not have to occur prior to randomization. Where local center regulations prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block and 5-20 unstained slides of whole sections of representative tumor tissue are preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block, 5-20 unstained slides of representative tumor tissue are also acceptable. Where no previously resected or biopsied tumor tissue exists or is available, on the approval of the Sponsor/designated CRO, the patient may still be considered eligible for the study. 20. Patient must consent to provision of a sample of blood in order that the specific correlative marker assays (Correlative Studies) may be conducted. 21. Patients must be accessible for treatment and follow up. Patients registered on this trial must receive protocol treatment and be followed at the participating center. This implies there must be reasonable geographical limits placed on patients being considered for this trial. Investigators must ensure that the patients randomized on this trial will be available for complete documentation of the treatment, response assessment, adverse events, and follow-up. 22. Protocol treatment is to begin within 2 calendar days of patient randomization for patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol treatment within 7 calendar days of randomization. 23. The patient is not receiving therapy in a concurrent clinical study and the patient agrees not to participate in other interventional clinical studies during their participation in this trial while on study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation. | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. |
| Progression Free Survival | From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. |
| Overall Response Rate | From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1). |
| Number of Patients With Adverse Events | Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months. | All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity. |
| Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks. | 8 weeks | QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate in Biomarker Positive Patients | From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. |
| Overall Response Rate in Biomarker Positive Patients | From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. |
| Progression Free Survival in Biomarker Positive Patients | From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. |
| Overall Survival in Biomarker Positive Patients | From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation. | To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue. |
Countries
Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, Ukraine, United States
Participant flow
Recruitment details
1134 participants were randomized between February 2017 and February 2019.
Pre-assignment details
Patients who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks. | 565 |
| Nab-paclitaxel With Gemcitabine All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks. | 569 |
| Total | 1,134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study Termination | 101 | 105 |
Baseline characteristics
| Characteristic | Napabucasin Plus Nab-paclitaxel With Gemcitabine | Nab-paclitaxel With Gemcitabine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 240 Participants | 274 Participants | 514 Participants |
| Age, Categorical Between 18 and 65 years | 325 Participants | 295 Participants | 620 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 194 Participants | 188 Participants | 382 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 8 Participants | 19 Participants |
| Race (NIH/OMB) White | 350 Participants | 354 Participants | 704 Participants |
| Sex: Female, Male Female | 240 Participants | 263 Participants | 503 Participants |
| Sex: Female, Male Male | 325 Participants | 306 Participants | 631 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 419 / 561 | 400 / 547 |
| other Total, other adverse events | 560 / 561 | 543 / 547 |
| serious Total, serious adverse events | 330 / 561 | 273 / 547 |
Outcome results
Primary
Overall Survival
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.
Time frame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Overall Survival | 11.43 Months |
| Nab-paclitaxel With Gemcitabine | Overall Survival | 11.73 Months |
Secondary
Disease Control Rate
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
Time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Disease Control Rate | 74 Percentage of participants |
| Nab-paclitaxel With Gemcitabine | Disease Control Rate | 76 Percentage of participants |
Secondary
Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.
QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.
Time frame: 8 weeks
Population: Each patient has 1 score selected from questionnaires collected from scheduled and unscheduled visits per scale per analysis window. If a patient had more than 1 questionnaire collected in an analysis window, the one collected closest to the target day is selected; if questionnaires had same days from the target day, the later one is selected; if questionnaires collected from the same date, the worst one is selected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks. | -1.63 Score on a scale | Standard Deviation 22.535 |
| Nab-paclitaxel With Gemcitabine | Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks. | -0.57 Score on a scale | Standard Deviation 23.402 |
Secondary
Number of Patients With Adverse Events
All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.
Time frame: Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Number of Patients With Adverse Events | 560 Participants |
| Nab-paclitaxel With Gemcitabine | Number of Patients With Adverse Events | 543 Participants |
Secondary
Overall Response Rate
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).
Time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Overall Response Rate | 43 Percentage |
| Nab-paclitaxel With Gemcitabine | Overall Response Rate | 43 Percentage |
Secondary
Progression Free Survival
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Progression Free Survival | 6.70 Months |
| Nab-paclitaxel With Gemcitabine | Progression Free Survival | 6.08 Months |
Other Pre-specified
Disease Control Rate in Biomarker Positive Patients
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
Time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Disease Control Rate in Biomarker Positive Patients | 75 Percentage |
| Nab-paclitaxel With Gemcitabine | Disease Control Rate in Biomarker Positive Patients | 79 Percentage |
Other Pre-specified
Overall Response Rate in Biomarker Positive Patients
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
Time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Overall Response Rate in Biomarker Positive Patients | 42 Percentage |
| Nab-paclitaxel With Gemcitabine | Overall Response Rate in Biomarker Positive Patients | 47 Percentage |
Other Pre-specified
Overall Survival in Biomarker Positive Patients
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
Time frame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Overall Survival in Biomarker Positive Patients | 11.40 Months |
| Nab-paclitaxel With Gemcitabine | Overall Survival in Biomarker Positive Patients | 10.78 Months |
Other Pre-specified
Progression Free Survival in Biomarker Positive Patients
To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
Time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Napabucasin Plus Nab-paclitaxel With Gemcitabine | Progression Free Survival in Biomarker Positive Patients | 5.68 Months |
| Nab-paclitaxel With Gemcitabine | Progression Free Survival in Biomarker Positive Patients | 5.82 Months |