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Metastatic Pancreatic CancerPhase 2/3NCT03721744

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

A Phase 2/3 study testing GB201, Paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by 1Globe Health Institute LLC at 38 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
GB201, Paclitaxel and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
336 participants
Where
38 sitesin 3 countries
Study dates
25 Oct 2018to Sep 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written, signed consent for trial participation in accordance with applicable ICH guidelines.
  • Must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
  • 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.
  • Must have one or more evaluable metastatic tumors by RECIST 1.1.
  • Must have ECOG Performance Status of 0 or 1.
  • Must have life-expectancy of > 12 weeks.
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  • Must be ≥ 18 years of age.
  • For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy.
  • 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.
  • Acceptable coagulation studies.
  • No clinically significant abnormalities on urinalysis.
  • Patient must have adequate nutritional status.
  • Pain symptoms should be stable (of tolerable Grade 2 or less).
  • Only patients with available archival tumor tissue must consent to submit block of tumor tissue.
  • The patient is not receiving therapy in a concurrent clinical study.

Who cannot join

  • 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.
  • Patients with any unresolved lingering toxicity > Grade 2 from prior treatment will be excluded.
  • Patient who were intolerant to prior taxane treatment.
  • Major surgery within 4 weeks prior to randomization.
  • Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
  • Patients with clinically significant pleural effusion or ascites.
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  • Patient with gastrointestinal disorder(s) which could significantly impede the absorption of an oral agent.
  • Prior treatment with napabucasin or participation in a clinical trial evaluating napabucasin.
  • Uncontrolled inter-current illness.
  • Known hypersensitivity to gemcitabine, taxanes or any of their excipients.
  • Uncontrolled chronic diarrhea ≥ grade 2 at baseline.
  • Patients being treated with any coumarins.
  • Patients with a history of other malignancies.

Trial locations and contacts

38 sites in 3 countries.

Shirley Yuan contact

+86-15901044003

yuanning@1globe-china.com

38 sites in 3 countries

China32 sites, 32 recruiting

  • Beijng Cancer Hospital

    Beijing, Beijing Municipality

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

    Recruiting

  • People's Hospital of Hunan Province

    Changsha, Hunan

    Recruiting

  • The Third Xianya Hospital of Central South University

    Changsha, Hunan

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong

    Recruiting

  • SUN YAT-SEN University Cancer Center

    Guangzhou, Guangdong

    Recruiting

  • Sir Run Shaw Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang

    Recruiting

  • The First Affiliated Hospital Zhejiang University

    Hangzhou, Zhejiang

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong

    Recruiting

  • The 81 Hospital of the Chinese People Liberation Army

    Nanjing, Jiangsu

    Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu

    Recruiting

  • East Hospital of Tongji University

    Shanghai, Shanghai Municipality

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Recruiting

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Recruiting

  • Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi

    Recruiting

  • Tianjin Medical University Cancer Institute Hospital

    Tianjin, Tianjin Municipality

    Recruiting

  • Union Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Recruiting

Other trials in China

France3 sites, 3 recruiting

  • Institut de Cancerologie de Lorraine

    Bourgogne

    Recruiting

  • Unité de Recherche Clinique en Cancérologie, Institut de cancérologie et d'hématologie

    Brest

    Recruiting

  • Centre Antoine Lacassagne

    Nice

    Recruiting

Other trials in France

Spain3 sites, 3 recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona

    Recruiting

  • Hospital Universitario HMN Sanchinarro

    Madrid

    Recruiting

  • Hospital Universitario La Paz

    Madrid

    Recruiting

Other trials in Spain

About this study

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

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

Being tested
GB201, Paclitaxel, Gemcitabine, Standard of care treatment options
Keywords
Pancreatic Cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB201Drug

    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

  • PaclitaxelDrug

    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

  • GemcitabineDrug

    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.

  • Standard of care treatment optionsOther

    Also called BSC

    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).

Study groups in NCT03721744
Study groupRoleWhat they receive
GB201+Paclitaxel+GemcitabineExperimentalPatients 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.
Receives: Drug: GB201; Drug: Paclitaxel; Drug: Gemcitabine
Standard of care treatment optionsActive comparatorPatients 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.
Receives: Other: Standard of care treatment options

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    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.

    Measured: 30 months

Secondary outcomes (5)

  1. Progression free survival (PFS)

    Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.

    Measured: 30 months

  2. 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

    Measured: 30 months

  3. 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

    Measured: 30 months

  4. 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

    Measured: 30 months

  5. Safety by reporting the adverse events and serious adverse events

    Assessment of safety of GB201 by reporting of adverse events and serious adverse events.

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2018
  2. Study start25 Oct 2018
  3. Primary completionMar 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03721744
Sponsor's protocol ID
STEMNESS-PANC
Status last verified
Apr 2024
First submitted
25 Oct 2018
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing GB201, Paclitaxel and Gemcitabine in people with Metastatic Pancreatic Cancer, run by 1Globe Health Institute LLC at 38 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in China, France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shirley Yuan (+86-15901044003, yuanning@1globe-china.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03721744.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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