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NCT05130021 | Unknown status | Metastatic Colorectal Cancer

A Clinical Study of Max-40279-01 in Patients With Advanced Colorectal Cancer
Sponsor:

Maxinovel Pty., Ltd.

Brief Summary:

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

Condition or disease

Metastatic Colorectal Cancer

Intervention/treatment

MAX-40279-01

regorafenib

Phase

Phase 2

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.}}

Study Type : Interventional
Estimated Enrollment : 130 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer
Actual Study Start Date : January 31, 2022
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : October 31, 2023
Arm Intervention/treatment

Experimental: Part 1;50mg

Drug: MAX-40279-01

Experimental: Part 1;70mg

Drug: MAX-40279-01

Experimental: Part 2;MAX-40279-01

Drug: MAX-40279-01

Experimental: Part 2;regorafenib

Drug: regorafenib
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 0-1.
  • 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.
A Clinical Study of Max-40279-01 in Patients With Advanced Colorectal Cancer

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Guangdong

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China,