A Phase III Clinical Study of Napabucasin (GB201) Plus FO... | NCT03522649

NCT03522649

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Napabucasin plus FOLFIRI	Experimental	Napabucasin 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.	Drug: Napabucasin Drug: Fluorouracil Drug: Leucovorin Drug: Irinotecan
Napabucasin	Other	Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours.	Drug: Napabucasin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Napabucasin	Drug	Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours.	Napabucasin Napabucasin plus FOLFIRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	43 months

Secondary Outcomes

Measure	Description	Time Frame
Progression free survival (PFS)	Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.	43 months
Objective response rate (ORR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
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

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Liu Wang	Contact	+86-10-62336199		wangliu@1globe-china.com

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Bengbu Medical College	Recruiting	Bengbu	Anhui	233004	China

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

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No data is available for this block.

Results Section

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No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1.

ID	Term
C000621033	napabucasin
D005472	Fluorouracil
D002955	Leucovorin
D000077146	Irinotecan

Ancestor Terms

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D005575	Formyltetrahydrofolates
D013763	Tetrahydrofolates
D005492	Folic Acid
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003067	Coenzymes
D045762	Enzymes and Coenzymes
D002166	Camptothecin
D000470	Alkaloids