Safety and Efficacy of Anlotinib in Combination With Irinotecan in Patients With Pretreated Advanced Colorectal Cancer

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT03545711
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Colo-rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 26, 2018
Status verified
Aug 2018
Primary completion
Nov 24, 2019
Completion
Nov 24, 2020

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anlotinib plus Irinotecan

Primary Outcome Measure

MTD [ Time Frame: 6 months ]

Central Contacts

Related Studies