A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer

Study Overview
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Brief Summary
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This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.

Detailed Description
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This study is a study of Max-40279-01 in patients with advanced colorectal cancer. This study include two Parts, the Part 1 will assess the safety and efficacy of the preset two dose level of Max-40279-01, and recommend a dose level of Max-40279-01 for stage 2. The part 2 is a randomized, controlled study ,and designed to compare the efficacy and safety of max-40279-01 to regorafenib or best support care(BSC) in pretreated advanced colorectal cancer.

Official Title
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A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: MAX-40279-01
* Drug: regorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and/or females over age 18 Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Expected survival >3 months. previously treated with standard, approved therapies, including two lines of chemotherapy (fluoropyrimidine,oxaliplatin and irinotecan based), a biological VEGF inhibitor, and, if RAS wild-type, an EGFR inhibitor. Patients with MSI-H/MMR-deficient tumors also must have received an immune checkpoint inhibitor, if available and approved. In addition, patients with BRAF mutant tumors must also have received a BRAF inhibitor, if available and approved. Signed informed consent form. Exclusion Criteria: Known uncontrolled or symptomatic central nervous system metastatic disease. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific exclusion criteria) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI CTCAE] v.3.0) at the time of randomization. Inadequate organ or bone marrow function. Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product. Pregnant or breast-feeding woman. Known allergies, hypersensitivity, or intolerance to Max-40279-01 the excipients of these treatments The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1;50mg<br> | Drug: MAX-40279-01<br>* MAX-40279-01 50mg/70mg<br>|
| Experimental: Part 1;70mg<br> | Drug: MAX-40279-01<br>* MAX-40279-01 50mg/70mg<br>|
| Experimental: Part 2;MAX-40279-01<br> | Drug: MAX-40279-01<br>* MAX-40279-01 50mg/70mg<br>|
| Experimental: Part 2;regorafenib<br> | Drug: regorafenib<br>* regorafenib<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR)[Part 1] |  | Through study Part 1 completion, an average of 6 months | 
| progress free survival(PFS)[Part 2] |  | Through study Part 1 completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax | Time to maximum plasma concentration | Approximately 6 months | 
| Cmax | Maximum plasma drug concentration | Approximately 6 months | 
| AUC | Area under the time-concentration curve | Approximately 6 months | 
| Objective response rate (ORR) |  | 6 months (anticipated) | 
| overall survival (OS) |  | 24 months | 
| Safety and tolerability assessed by incidence and severity of adverse events |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic colorectal cancer, pretreated