History of Changes for Study: NCT03721744

A Study of Napabucasin(GB201) in Combination With Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer

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Study Record Versions

Version	Submitted Date	Changes
1	October 25, 2018	None (earliest Version on record)
2	October 26, 2018	Outcome Measures and Study Status
3	November 23, 2018	Recruitment Status, Study Status and Contacts/Locations
4	January 22, 2019	Study Identification, Arms and Interventions, Sponsor/Collaborators, Eligibility and Study Status
5	June 17, 2019	Study Status and Study Identification
6	April 1, 2024	Arms and Interventions, Study Status, Outcome Measures, Contacts/Locations, Study Design, Study Identification, Eligibility and Study Description

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Merged
Side-by-Side

Study Identification


Unique Protocol ID:	PANC333
Brief Title:	A Study of Napabucasin(GB201) in Combination With 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
Secondary IDs:

Study Status


Record Verification:	October 2018
Overall Status:	Not yet recruiting
Study Start:	October 2018
Primary Completion:	December 2021 [Anticipated]
Study Completion:	December 2021 [Anticipated]

First Submitted:	October 25, 2018
First Submitted that Met QC Criteria:	October 25, 2018
First Posted:	October 26, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	October 25, 2018
Last Update Posted:	October 26, 2018 [Actual]

Sponsor/Collaborators


Sponsor:	1Globe Biomedical Co., Ltd.
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:

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
Detailed Description:

Conditions


Conditions:	Metastatic Pancreatic Cancer
Keywords:	Pancreatic Cancer

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	230 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Napabucasin+Paclitaxel+Gemcitabine

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

Drug: Napabucasin

Napabucasin will be administered twice daily, at 240 mg bid (480 mg total daily dose), one hour prior or two hours after meals

Other Names:

GB201

Drug: Paclitaxel

Paclitaxel 80 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle

Other Names:

Bendatax

Drug: Gemcitabine

Gemcitabine 600 mg/m^2 will be administered intravenously following paclitaxel infusion on Days 1, 8 and 15 of every 28-day cycle

Other Names:

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), one of which will be assigned by the investigator for each patient.

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), one of which will be assigned by the investigator, per Investigator decision

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	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.
2.	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
3.	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
4.	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.
5.	Quality of Life (QoL) [ Time Frame: 30 months ] QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30)

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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 local advanced or metastatic setting. Patient has experienced a decline in ECOG performance status between baseline visit and within 3 days prior to randomization

Contacts/Locations


Central Contact Person:	Shirley Yuan Telephone: +86-15901044003 Email: yuanning@1globe-china.com
Locations:	China, Jiangsu
	The 81st Hospital of Chinese PLA Nanjing, Jiangsu, China

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