Phase 2 N=71 Randomized Quadruple-blind Treatment

Study of Fruquintinib in Patients With Metastatic Colorectal Cancer

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02196688 ↗

Enrolled (actual)

Serious AEs

23.9%

Results posted

Aug 2019

Primary outcome: Primary: Progression Free Survival (PFS) — 4.731; 0.986 months

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: fruquintinib (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hutchison Medipharma Limited
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression Free Survival (PFS)	4.731; 0.986	—
SECONDARY Objective Response Rate (ORR)	1; 0	—
SECONDARY Disease Control Rate (DCR)	32; 5	—
SECONDARY Over Survival (OS)	7.721; 5.520	—

Summary

Fruquintinib administered at 5mg once daily in 4 weeks treatment cycle (three weeks on and one week off) was well tolerated and demonstrated encouraging preliminary clinical antitumor activity in patients with advanced Colorectal Cancer (CRC) in Phase Ib study. This study is aimed to evaluate the efficacy and safety of Fruquintinib in the treatment of patients with metastatic CRC who have progressed after metastatic CRC second line or above standard chemotherapy.

Eligibility Criteria

Inclusion Criteria

≥ 18 and ≤ 75 years of age , with ≥ 40 Kg
Histological or cytological confirmed metastatic colorectal cancer
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Failed 2 or more lines of chemotherapy
Adequate hepatic, renal, heart, and hematologic functions
At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
Signed and dated informed consent.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria

Pregnant or lactating women
Any factors that influence the usage of oral administration
Central nervous system (CNS) metastasis
One of the following conditions: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
Abuse of alcohol or drugs
Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition
Disability of serious uncontrolled intercurrence infection
Proteinuria ≥ 2+ (1.0g/24hr)
Evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness
History of artery/venous thromboembolic events in 12 months, such as cerebral vascular accident (including transient ischemic attack) etc.
History of acute myocardial infarction, acute coronary syndrome or coronary artery bypass graft (CABG) in 6 months
Bone fracture or wounds that was not cured for a long time
Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02196688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.