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NCT03545711

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

Status unknown Phase 1, PHASE2 Last updated 6 August 2018
What this trial tests

Phase 1, PHASE2 trial testing Anlotinib Hydrochloride with Irinotecan in Colo-rectal Cancer in 42 participants. Status unknown.

Timeline
26 May 2018
Primary endpoint
24 November 2019
24 November 2020

Quick facts

Lead sponsorChinese Academy of Medical Sciences
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment42
Start date26 May 2018
Primary completion24 November 2019
Estimated completion24 November 2020
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chinese Academy of Medical Sciences — full company profile →

Who can join

Adults 18 to 70, any sex, with Colo-rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Anlotinib as a molecular targeted therapy for tumors.
    Gao Y, Liu P, Shi R. · · 2020 · cited 108× · PMID 32724339 · DOI 10.3892/ol.2020.11685

Verify or expand the search:

Other recruiting trials for Colo-rectal Cancer

Currently open trials in the same condition.

Other Chinese Academy of Medical Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03545711.

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