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

Maxinovel Pty., Ltd.1 site in 1 country130 target enrollmentJanuary 31, 2022

ConditionsMetastatic Colorectal Cancer

InterventionsMAX-40279-01 regorafenib

DrugsMAX-40279-01 regorafenib

Overview

Phase: Phase 2
Intervention: MAX-40279-01
Conditions: Metastatic Colorectal Cancer
Sponsor: Maxinovel Pty., Ltd.
Enrollment: 130
Locations: 1
Primary Endpoint: Disease control rate (DCR)[Part 1]
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

January 31, 2022

End Date

October 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maxinovel Pty., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.

Arms & Interventions

Part 1;50mg

Intervention: MAX-40279-01

Part 1;70mg

Intervention: MAX-40279-01

Part 2;MAX-40279-01

Intervention: MAX-40279-01

Part 2;regorafenib

Intervention: regorafenib

Outcomes

Primary Outcomes

Disease control rate (DCR)[Part 1]

Time Frame: Through study Part 1 completion, an average of 6 months

progress free survival(PFS)[Part 2]

Time Frame: Through study Part 1 completion, an average of 6 months

Secondary Outcomes

overall survival (OS)(24 months)
Tmax(Approximately 6 months)
Safety and tolerability assessed by incidence and severity of adverse events(24 months)
Objective response rate (ORR)(6 months (anticipated))
Cmax(Approximately 6 months)
AUC(Approximately 6 months)