Back to resultsA Study of Napabucasin in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
Primary Purpose
Metastatic Pancreatic Cancer
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Napabucasin
Paclitaxel
Gemcitabine
Standard of care treatment options
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
- Must have at least failed first line therapy
- 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
Exclusion Criteria:
- Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of chemotherapy within period of time equivalent to the usual cycle length of the regimen
- Prior taxane therapy in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxane therapy in the locally advanced or metastatic setting.
- Patient has experienced a decline in ECOG performance status between baseline visit and within 3 days prior to randomization
Sites / Locations
- The 81st Hospital of Chinese PLARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Napabucasin+Paclitaxel+Gemcitabine
Standard of care treatment options
Arm Description
Napabucasin will be administered twice daily, at 240 mg bid (480 mg total daily dose).Paclitaxel 80 mg/m^2 will be administered intravenously. Gemcitabine 600 mg/m^2 will be administered intravenously following paclitaxel infusion. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression based on RECIST 1.1 criteria
Patients will receive standard of care treatment options treatment, including Fluorouracil and Leucovorin, Gemcitabine, Onivyde plus Fluorouracil and Leucovorin (if Onivyde has been approved to treat pancreatic cancer in the country/region), or best supportive care (BSC) alone, one of which will be assigned by the investigator for each patient.
Outcomes
Primary Outcome Measures
Overall survival (OS)
The primary objective of this study is to compare overall survival (OS) of patients with metastatic pancreatic adenocarcinoma treated with Napabucasin in combination with weekly paclitaxel and Low-dose gemcitabine versus standard of care treatment options.
Secondary Outcome Measures
Progression free survival (PFS)
Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Objective response rate (ORR)
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1
Disease control rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1
Number of Patients with Adverse Events
All patients who have received at least one dose of Napabucasin will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.
Quality of Life (QoL)
European Organization for Research and Treatment of Cancer Quality of Life questionnaire（EORTC-QLQ-C30), is a self-administered cancer specific questionnaire with multi-dimensional scales. It consists of both multi-item scales and single item measures, including five functional domains, a global quality of life domain, three symptom domains, and six single items. For each domain or single item measure a linear transformation will be applied to standardize the raw score to range between 0 and 100. The endpoints in QoL analysis are the mean EORTC QLQ-C30 QoL change scores from baseline for the physical function and global health status/quality of life subscale scores. After transformation, higher scores in these two subscales mean better outcome
Full Information
NCT ID
NCT03721744
First Posted
October 25, 2018
Last Updated
June 17, 2019
Sponsor
1Globe Health Institute LLC
1. Study Identification
Unique Protocol Identification Number
NCT03721744
Brief Title
A Study of Napabucasin in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
Official Title
A Phase III Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic PANCreatic Cancer Following Front-Line Chemotherapy Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
1Globe Health Institute LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a Phase III Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Front-Line Chemotherapy Failure
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Napabucasin+Paclitaxel+Gemcitabine
Arm Type
Experimental
Arm Description
Napabucasin will be administered twice daily, at 240 mg bid (480 mg total daily dose).Paclitaxel 80 mg/m^2 will be administered intravenously. Gemcitabine 600 mg/m^2 will be administered intravenously following paclitaxel infusion. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle. Patients may continue to receive protocol therapy as long as they have not experienced any adverse events requiring permanent discontinuation of study medication and have not demonstrated disease progression based on RECIST 1.1 criteria
Arm Title
Standard of care treatment options
Arm Type
Active Comparator
Arm Description
Patients will receive standard of care treatment options treatment, including Fluorouracil and Leucovorin, Gemcitabine, Onivyde plus Fluorouracil and Leucovorin (if Onivyde has been approved to treat pancreatic cancer in the country/region), or best supportive care (BSC) alone, one of which will be assigned by the investigator for each patient.
Intervention Type
Drug
Intervention Name(s)
Napabucasin
Other Intervention Name(s)
GB201
Intervention Description
Napabucasin will be administered twice daily, at 240 mg bid (480 mg total daily dose), one hour prior or two hours after meals
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Bendatax
Intervention Description
Paclitaxel 80 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Bendacitabin
Intervention Description
Gemcitabine 600 mg/m^2 will be administered intravenously following paclitaxel infusion on Days 1, 8 and 15 of every 28-day cycle
Intervention Type
Other
Intervention Name(s)
Standard of care treatment options
Intervention Description
Patient will receive standard of care treatment options, including Fluorouracil /Leucovorin, Gemcitabine, Onivyde plus Fluorouracil /Leucovorin (if Onivyde has been approved to treat pancreatic cancer in the country/region) or best supportive care (BSC) alone, one of which will be assigned by the investigator, per Investigator decision
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
The primary objective of this study is to compare overall survival (OS) of patients with metastatic pancreatic adenocarcinoma treated with Napabucasin in combination with weekly paclitaxel and Low-dose gemcitabine versus standard of care treatment options.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Time Frame
30 months
Title
Objective response rate (ORR)
Description
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1
Time Frame
30 months
Title
Disease control rate (DCR)
Description
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
30 months
Title
Number of Patients with Adverse Events
Description
All patients who have received at least one dose of Napabucasin will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.
Time Frame
30 months
Title
Quality of Life (QoL)
Description
European Organization for Research and Treatment of Cancer Quality of Life questionnaire（EORTC-QLQ-C30), is a self-administered cancer specific questionnaire with multi-dimensional scales. It consists of both multi-item scales and single item measures, including five functional domains, a global quality of life domain, three symptom domains, and six single items. For each domain or single item measure a linear transformation will be applied to standardize the raw score to range between 0 and 100. The endpoints in QoL analysis are the mean EORTC QLQ-C30 QoL change scores from baseline for the physical function and global health status/quality of life subscale scores. After transformation, higher scores in these two subscales mean better outcome
Time Frame
30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
Must have at least failed first line therapy
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
Exclusion Criteria:
Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of chemotherapy within period of time equivalent to the usual cycle length of the regimen
Prior taxane therapy in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxane therapy in the locally advanced or metastatic setting.
Patient has experienced a decline in ECOG performance status between baseline visit and within 3 days prior to randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Yuan
Phone
+86-15901044003
Email
yuanning@1globe-china.com
Facility Information:
Facility Name
The 81st Hospital of Chinese PLA
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study of Napabucasin in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
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