Trials / Unknown
UnknownNCT04337879
A Study of AL2846 Capsule Combined With Standard Chemotherapy Regimen in Subjects With Advanced Colorectal Cancer
A Phase Ib Study to Evaluate the Efficacy and Safety of AL2846 Capsule Combined With Chemotherapy (mFOLFOX6 or FOLFIRI)Versus Placebo Combined With Chemotherapy in Subjects With Advanced Colorectal Cancer
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study to explore the safety, tolerance and efficacy of AL2846 capsules combined with mFOLFOLX6 or FOLFIRI standard chemotherapy regimen in subjects with advanced metastatic colorectal cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AL2846 | AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met. |
| DRUG | Calcium folate | Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle |
| DRUG | 5-FU | 5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle. |
| DRUG | Oxaliplatin | Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle. |
| DRUG | Irinotecan | Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle. |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2020-04-08
- Last updated
- 2020-07-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04337879. Inclusion in this directory is not an endorsement.