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Previously Treated Metastatic Colorectal CancerPhase 3NCT03522649

A Phase III Clinical Study of Napabucasin (GB201) Plus FOLFIRI in Adult Patients With Metastatic Colorectal Cancer

A Phase 3 study testing Napabucasin, Fluorouracil and Leucovorin in people with Previously Treated Metastatic Colorectal Cancer, run by 1Globe Health Institute LLC at 37 sites in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Napabucasin, Fluorouracil and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
668 participants
Where
37 sitesChina
Study dates
12 Apr 2018to Nov 2021
Phase
Phase 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

  • Histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (Stage IV)
  • Progression during or within 3 months following the last administration of standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin. Patients treated with oxaliplatin or irinotecan in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy
  • Patients who are candidates for and have access to anti-VEGF therapy (i.e. bevacizumab and regorafenib) and anti-EGFR therapy (i.e. cetuximab and panitumumab) and/or TAS-102 must have received appropriate therapy.
  • Patients with measurable or non measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
  • Adequate bone marrow, liver and renal function

Who cannot join

  • Anti-cancer chemotherapy, biologic therapy or any other systemic therapy if administered prior to the first planned dose of study medication within period of time equivalent to the usual cycle length of the regimen. An exception is made for oral fluoropyrimidines (e.g. capecitabine, S-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of protocol treatment.
  • Major surgery within 4 weeks prior to randomization.
  • Any known brain or leptomeningeal metastases are excluded, even if treated.
  • Known hypersensitivity to 5-FU/LV or patients who as a result of toxicity had to reduce or stop 5-FU infusion at the dose of 900 mg/m^2/day (total 1800 mg/m^2/day).
  • Known hypersensitivity to irinotecan or patients who as a result of toxicity had to reduce or stop irinotecan infusion at the dose of 120 mg/m^2.
  • Known history of human immunodeficiency virus (HIV) infection. Known chronic hepatitis B or C active infection.
Show all 10Show fewer
  • Known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Patients with QTc interval > 470 millisecond.
  • Uncontrolled intercurrent illness

Trial locations and contacts

37 sites in 1 country.

Liu Wang contact

+86-10-62336199

wangliu@1globe-china.com

37 sites in 1 country

China37 sites, 37 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Beijng Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Recruiting

  • First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

    Recruiting

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

    Recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

    Recruiting

  • The Sixth Affiliated Hospital of Sun Yat - sen University

    Guangzhou, Guangdong, 510655

    Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310006

    Recruiting

  • The Second Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310009

    Recruiting

  • Sir Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310016

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150040

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Recruiting

  • The 81 Hospital of the Chinese People's Liberation Army

    Nanjing, Jiangsu, 210002

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Recruiting

  • Jiangsu Provence Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • The Affiliated Hospital Qingdao University

    Qingdao, Shandong, 266103

    Recruiting

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

    Recruiting

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Recruiting

  • Ren Ji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200127

    Recruiting

  • Liaoning Provincial Cancer Hospital

    Shenyang, Liaoning, 110042

    Recruiting

  • Forth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Recruiting

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

    Wuhan, Hubei, 430023

    Recruiting

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

    Wuhan, Hubei, 430030

    Recruiting

  • The First Affiliated Hospital of Xi' AnJiaotong University

    Xi’an, Shanxi, 710061

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

About this study

Official title: A Phase III, Randomized, Open-Label Clinical Study of Napabucasin (GB201) in Combination With FOLFIRI Versus Napabucasin in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CRC)

This is a randomized, open-label, multi-center, phase III study of Napabucasin plus bi-weekly FOLFIRI (Arm 1) vs. Napabucasin (Arm 2) for adult patients with metastatic CRC who have failed standard chemotherapy regimens. For patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with FOLFIRI to patients randomized to Arm 1.

Being tested
Napabucasin, Fluorouracil, Leucovorin, Irinotecan
Keywords
CRC

What participants receive

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

  • NapabucasinDrug

    Also called GB201

    Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours.

  • FluorouracilDrug

    Also called 5-FU, Benda-5 FU

    Fluorouracil 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by Fluorouracil 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion.

  • LeucovorinDrug

    Also called Folinic Acid

    Irinotecan 180 mg/m^2 followed by or concurrent with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively.

  • IrinotecanDrug

    Also called Irinotecan Aurobindo

    Irinotecan 180 mg/m^2 followed by or concurrent with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively.

Study groups in NCT03522649
Study groupRoleWhat they receive
Napabucasin plus FOLFIRIExperimentalNapabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours. For patients who have failed bevacizumab with irinotecan-based chemotherapies, bevacizumab may be administered with FOLFIRI. FOLFIRI infusion will start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks, starting on C1D1. If bevacizumab is added to FOLFIRI, bevacizumab infusion should start at least 2 hours following the first daily dose of napabucasin and will be administered every 2 weeks. Irinotecan/leucovorin infusion will follow bevacizumab infusion. 5-FU 400 mg/ m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by 5-FU 1200 mg/ m^2/day continuous infusion. For patients who could not tolerate FOLFIRI at the full dose previously, FOLFIRI should be started at the same dose level the patient tolerated FOLFIRI previously.
Receives: Drug: Napabucasin; Drug: Fluorouracil; Drug: Leucovorin; Drug: Irinotecan
NapabucasinOtherNapabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours.
Receives: Drug: Napabucasin

What is being measured

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

  1. Overall Survival (OS)

    To assess the effect of Napabucasin plus biweekly FOLFIRI versus Napabucasin on the Overall Survival of patients with previously treated metastatic colorectal cancer.

    Measured: 43 months

Secondary outcomes (9)

  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: 43 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: 43 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: 43 months

  4. Number of Patients with Adverse Events

    All patients who have received at least one dose of Napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.

    Measured: 43 months

  5. Quality of Life (QoL)

    QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with pretreated metastatic CRC treated with Napabucasin plus biweekly FOLFIRI versus Napabucasin.

    Measured: 43 months

  6. Overall Survival in biomarker positive patients

    To assess the effect of Napabucasin plus FOLFIRI versus Napabucasin on the Overall Survival of patients with metastatic colorectal cancer in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3/nuclear β-catenin positivity on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) archival tissue.

    Measured: 43 months

  7. Progression Free Survival in biomarker positive patients

    Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with nuclear β-catenin and/or phospho-STAT3 positivity on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) archival tissue.

    Measured: 43 months

  8. Objective Response Rate in biomarker positive patients

    Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1. This biomarker-positive sub-population is defined as those patients with nuclear β-catenin and/or phospho-STAT3 positivity on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) archival tissue.Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1. This biomarker-positive sub-population is defined as those patients with nuclear β-catenin and/or phospho-STAT3 positivity on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) archival tissue.

    Measured: 43 months

  9. Disease Control Rate in biomarker positive patients

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1. This biomarker-positive sub-population is defined as those patients with nuclear β-catenin and/or phospho-STAT3 positivity on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) archival tissue.

    Measured: 43 months

Timeline

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

  1. First posted11 May 2018
  2. Study start12 Apr 2018
  3. Primary completionNov 2021 (estimated)
  4. Study completionNov 2021 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
668 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03522649
Sponsor's protocol ID
STEMNESS-CRC
Status last verified
May 2019
First submitted
1 May 2018
Last updated
18 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Napabucasin, Fluorouracil and Leucovorin in people with Previously Treated Metastatic Colorectal Cancer, run by 1Globe Health Institute LLC at 37 sites in China.

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 6 inclusion and 10 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 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. 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 phase mean?

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 Liu Wang (+86-10-62336199, wangliu@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: 43 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 NCT03522649.

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 18 Jun 2019.

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