Trials / Unknown
UnknownNCT05130021
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Maxinovel Pty., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MAX-40279-01 | MAX-40279-01 50mg/70mg |
| DRUG | regorafenib | regorafenib |
Timeline
- Start date
- 2022-01-31
- Primary completion
- 2022-05-30
- Completion
- 2023-10-31
- First posted
- 2021-11-22
- Last updated
- 2021-12-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05130021. Inclusion in this directory is not an endorsement.