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Trial record 1 of 1 for:    STEMNESS-PANC
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A Study of GB201 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 : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
1Globe Biomedical Co., Ltd. ( 1Globe Health Institute LLC )

Study Description
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Brief Summary:
This is a Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: GB201 Drug: Paclitaxel Drug: Gemcitabine Other: Standard of care treatment options Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: GB201+Paclitaxel+Gemcitabine

Patients randomized to Arm 1 will receive GB201 in combination with weekly paclitaxel and low-dose gemcitabine, with one treatment cycle defined as 4 weeks (28 days). GB201 will be administered orally, twice daily, with doses separated by approximately 8-12 hours. GB201 administration will begin 2-5 days prior to the first infusion of paclitaxel and low-dose gemcitabine.

Paclitaxel and low-dose gemcitabine will be administered on Days 1, 8 and 15 of every 28-day cycle.

 Drug: GB201
GB201 will be administered orally, twice daily, with doses separated by approximately 8-12 hours. GB201 administration will begin 2-5 days prior to the first infusion of paclitaxel and low-dose gemcitabine

Drug: Paclitaxel
Paclitaxel 80 mg/m^2 will be administered intravenously starting on Day 1 of Cycle 1. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle

Drug: Gemcitabine
Low-dose gemcitabine 600 mg/m^2 will be administered intravenously following completion of paclitaxel infusion. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle.
Active Comparator: Standard of care treatment options
Patients randomized to Arm 2 will receive one of the standard of care treatment options assigned by the Investigator for each patient prior to starting protocol treatment, including gemcitabine, capecitabine, 5-FU/LV, Onivyde plus 5- FU/LV (if Onivyde is available in the country/region) or best supportive care (BSC). Patients who have failed gemcitabine previously and were randomized to Arm 2 will not be eligible to receive gemcitabine as a treatment option.
 Other: Standard of care treatment options
Patients will receive one of the standard of care treatment options assigned by the Investigator for each patient prior to starting protocol treatment, including Gemcitabine, capecitabine, 5-FU/LV, Onivyde plus 5-FU/LV (if Onivyde is available in the country/region) or best supportive care (BSC).
Other Name: BSC


Outcome Measures
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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 GB201 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. 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

  5. Safety by reporting the adverse events and serious adverse events [ Time Frame: 30 months ]
    Assessment of safety of GB201 by reporting of adverse events and serious adverse events.


Eligibility Criteria
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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

  1. Written, signed consent for trial participation in accordance with applicable ICH guidelines.
  2. Must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
  3. Patients who are candidates for and have access to gemcitabine-nab-paclitaxel or are candidates for FOLFIRINOX/mFOLFIRINOX must have received these standard of care regimens before randomization.
  4. Must have one or more evaluable metastatic tumors by RECIST 1.1.
  5. Must have ECOG Performance Status of 0 or 1.
  6. Must have life-expectancy of > 12 weeks.
  7. Must be ≥ 18 years of age.
  8. For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy.

  9. Adequate biological parameters：

    • Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
    • Platelet count ≥ 100,000/mm^3 (100 × 10^9/L).
    • Hemoglobin (Hgb) ≥ 9 g/dL.
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) [5 ×ULN in presence of liver metastases]
    • Total bilirubin ≤ 1.5 × institutional ULN. If total bilirubin is > ULN, it must be non-rising for at least 3 days.
    • Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73 m^2.
  10. Acceptable coagulation studies.
  11. No clinically significant abnormalities on urinalysis.
  12. Patient must have adequate nutritional status.
  13. Pain symptoms should be stable (of tolerable Grade 2 or less).
  14. Only patients with available archival tumor tissue must consent to submit block of tumor tissue.
  15. The patient is not receiving therapy in a concurrent clinical study.

EXCLUSION CRITERIA

  1. Anti-cancer chemotherapy, radiotherapy, biologic therapy or immunotherapy administered two weeks prior to the first planned dose of study medication. Investigational agents administered within four weeks of first planned dose of study medication.
  2. Patients with any unresolved lingering toxicity > Grade 2 from prior treatment will be excluded.
  3. Patient who were intolerant to prior taxane treatment.
  4. Major surgery within 4 weeks prior to randomization.
  5. Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
  6. Patients with clinically significant pleural effusion or ascites.
  7. Patient with gastrointestinal disorder(s) which could significantly impede the absorption of an oral agent.
  8. Prior treatment with napabucasin or participation in a clinical trial evaluating napabucasin.
  9. Uncontrolled inter-current illness.
  10. Known hypersensitivity to gemcitabine, taxanes or any of their excipients.
  11. Uncontrolled chronic diarrhea ≥ grade 2 at baseline.
  12. Patients being treated with any coumarins.
  13. Patients with a history of other malignancies.
Contacts and Locations
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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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Sponsors and Collaborators
1Globe Health Institute LLC
More Information
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Responsible Party: 1Globe Health Institute LLC
ClinicalTrials.gov Identifier: NCT03721744    
Other Study ID Numbers: STEMNESS-PANC
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024

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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
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
 Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites