Trials / Unknown
UnknownNCT03545711
Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer
Safety and Efficacy of Irinotecan Combined With Anlotinib in Patients With Pretreated Advanced Colorectal Cancer
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- Chinese Academy of Medical Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Patients with pretreated advanced colorectal cancer are recruited to the phase I portion of this prospective non-randomised study in an escalated dose cohort. The primary endpoint of the dose-escalation phase is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of anlotinib when given in combination with irinotecan. The phase II (dose-expansion) portion is designed to characterize the safety and potential efficacy of the combination therapy in pretreated advanced colorectal cancer patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Anlotinib Hydrochloride with Irinotecan | Dose escalation of anlotinib starts from 8mg qd d1-14/q21d in combination with fixed dose of irinotecan at 180mg/m2 d1/q14d. |
Timeline
- Start date
- 2018-05-26
- Primary completion
- 2019-11-24
- Completion
- 2020-11-24
- First posted
- 2018-06-04
- Last updated
- 2018-08-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03545711. Inclusion in this directory is not an endorsement.