Metastatic Colorectal Cancer
Conditions
Keywords
metastatic colorectal cancer, pretreated
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.
Interventions
DRUGMAX-40279-01
MAX-40279-01 50mg/70mg
DRUGregorafenib
regorafenib
Sponsors
Maxinovel Pty., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and/or females over age 18 2. Histologically and/or cytologically documented local advanced or metastatic colorectal adenocarcinoma. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Expected survival \>3 months. 5. 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. 6. Signed informed consent form.
Exclusion criteria
1. Known uncontrolled or symptomatic central nervous system metastatic disease. 2. Adverse events (with exception of alopecia, peripheral sensory neuropathy grade ≤ 2 and those listed in specific
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| AUC | Approximately 6 months | Area under the time-concentration curve |
| Objective response rate (ORR) | 6 months (anticipated) | — |
| Tmax | Approximately 6 months | Time to maximum plasma concentration |
| Safety and tolerability assessed by incidence and severity of adverse events | 24 months | — |
| overall survival (OS) | 24 months | — |
| Cmax | Approximately 6 months | Maximum plasma drug concentration |
Countries
China
Contacts
Primary ContactHanying Bao, MD,Ph.D
Backup ContactYanhong Y Deng, Dr
Outcome results
None listed