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Trial record 34 of 2842 for:    Pancreatic Cancer

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
Sponsor:
Information provided by (Responsible Party):
1Globe Biomedical Co., Ltd. ( 1Globe Health Institute LLC )

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

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: Napabucasin Drug: Paclitaxel Drug: Gemcitabine Other: Standard of care treatment options Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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 Name: GB201

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




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. 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.

  2. 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

  3. 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

  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 ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 locally advanced or metastatic setting.
  • Patient has experienced a decline in ECOG performance status between baseline visit and within 3 days prior to randomization

Information from the National Library of Medicine

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


Contacts
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Contact: Shirley Yuan +86-15901044003 yuanning@1globe-china.com

Locations
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China, Jiangsu
The 81st Hospital of Chinese PLA Recruiting
Nanjing, Jiangsu, China
Sponsors and Collaborators
1Globe Health Institute LLC

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Responsible Party: 1Globe Health Institute LLC
ClinicalTrials.gov Identifier: NCT03721744     History of Changes
Other Study ID Numbers: STEMNESS-PANC
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 1Globe Biomedical Co., Ltd. ( 1Globe Health Institute LLC ):
Pancreatic Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs