A Study of Napabucasin in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03721744|
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: Napabucasin Drug: Paclitaxel Drug: Gemcitabine Other: Standard of care treatment options||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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
Napabucasin will be administered twice daily, at 240 mg bid (480 mg total daily dose), one hour prior or two hours after meals
Other Name: GB201
Paclitaxel 80 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle
Other Name: Bendatax
Gemcitabine 600 mg/m^2 will be administered intravenously following paclitaxel infusion on Days 1, 8 and 15 of every 28-day cycle
Other Name: Bendacitabin
Active Comparator: Standard of care treatment options
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.
Other: Standard of care treatment options
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
- Overall survival (OS) [ Time Frame: 30 months ]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.
- Progression free survival (PFS) [ Time Frame: 30 months ]Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
- Objective response rate (ORR) [ Time Frame: 30 months ]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) [ Time Frame: 30 months ]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 [ Time Frame: 30 months ]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) [ Time Frame: 30 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721744
|Contact: Shirley Yuanemail@example.com|
|The 81st Hospital of Chinese PLA||Recruiting|
|Nanjing, Jiangsu, China|