A Clincal Study of Max-40279-01 in Patients With Advanced Colorectal Cancer
A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Colorectal Cancer
1 other identifier
interventional
130
1 country
1
Brief Summary
This include two parts, part 1 is a dose optimizing study and part 2 is a randomized, controlled study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Start
First participant enrolled
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedDecember 6, 2021
November 1, 2021
4 months
November 10, 2021
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Tmax
Approximately 6 months
Cmax
Approximately 6 months
AUC
Approximately 6 months
Objective response rate (ORR)
6 months (anticipated)
overall survival (OS)
24 months
- +1 more secondary outcomes
Study Arms (4)
Part 1;50mg
EXPERIMENTALPart 1;70mg
EXPERIMENTALPart 2;MAX-40279-01
EXPERIMENTALPart 2;regorafenib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
January 31, 2022
Primary Completion
May 30, 2022
Study Completion
October 31, 2023
Last Updated
December 6, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share