Brief Summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, whose anti-tumor and anti-angiogenesis effects have been validated in preclinical tests. In PhaseⅡb study, a significantly improved Progression Free Survival (PFS) was found in patients with advanced colorectal cancer treated with Famitinib compared to placebo. On the other hand, the toxicity of Famitinib was manageable in both PhaseⅠand Ⅱb studies. The purpose of this study is to determine whether Famitinib can improve Overall Survival (OS) compared with placebo in total 540 patients with advanced colorectal cancer who have failed in previously received at least two lines of standard chemotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

543

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jan 2015

Longer than P75 for phase_3

Geographic Reach

1 country

44 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

Study Start

First participant enrolled

January 1, 2015

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed

20 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed

Last Updated

December 22, 2020

Status Verified

May 1, 2017

Enrollment Period

4.1 years

First QC Date

February 26, 2015

Last Update Submit

December 21, 2020

Conditions

Colorectal Cancer Metastatic Colorectal Cancer Recurrent

Keywords

Colorectal CancerFamitinib

Outcome Measures

Primary Outcomes (1)

Overall Survival(OS)
3 years

Secondary Outcomes (6)

Progression Free Survival(PFS)
1.5 years
Objective response rate(ORR)
6 months
Disease Control Rate(DCR)
1.5 years
Quality of Life as measured by EORTC QLQ-C30(3.0)
1.5 years
The incidence of Adverse Events
3 years
+1 more secondary outcomes

Study Arms (2)

Famitinib arms

EXPERIMENTAL

Famitinib 25 mg p.o. qd and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Famitinib

Control arms

PLACEBO COMPARATOR

Placebo 25 mg p.o. qd and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent

Drug: Placebo

Interventions

FamitinibDRUG

25 mg p.o. qd

Famitinib arms

PlaceboDRUG

25 mg p.o. qd

Control arms

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female patients aged 18 to 75 (including 18 and 75) at the time of Informed Consent
Pathologically confirmed advanced colorectal adenocarcinoma (all the other histological types are excluded)
Treatment failure in previously received standard therapy (at least two lines), which must include 5-Fu, irinotecan and oxaliplatin
Definition of "treatment failure":
A.Disease progression during experimental drug treatment or within 3 months after the last treatment, with definite imaging or clinical evidences;
B.For patients abandoning chemotherapy because of intolerance of advent events, hematologic toxicity is required to reach ≥Grade IV (platelet decrease ≥ Grade III ), and nonhematologic toxicity is required to reach ≥Grade III , according to NCI CTCAE 4.0. Furthermore, the original treatment should be not tolerated any more when it is repeated to the same patient, judged by investigators.
Note:
A.When adjuvant therapy including oxaliplatin was previously used, at least 9 courses of FOLFOX (2 weeks regimens), 6 courses of CapeOX (3 week regimen), or 750mg/m\^2 cumulative consumption of oxaliplatin, are required. Adjuvant therapy will be regarded as the first-line treatment when disease progressed during or within 6 months after treatments
B.Monoclonal antibody drugs (bevacizumab, cetuximab, panitumumab, aflibercept, etc.) are allowed to combine with prior chemotherapy.
At least one measurable targeting lesion according to RECIST 1.1 (The diameter of tumor and lymph node lesion should be ≥ 10 mm and 15mm, respectively, with scanning layer ≤ 5 mm and without local treatment)
Eastern Cooperative Oncology Group (ECOG) performance status:0-1.
Life expectancy ≥ 3 months
Adequate function of major organs, meaning the following criteria should be met within 14 days before randomization:
A.Routine blood test:
Hemoglobin \> 90g/L (not received blood transfusion or drugs to incraese RBC, Hb, WBC and PLT in 14 days before screening )
+10 more criteria

You may not qualify if:

Second malignancies, except for cured skin basal cell carcinoma and carcinoma in-situ of uterine cervix, before or during screening
Previously received therapy of tyrosine kinase inhibitor agent targeting at VEGFR, e.g. famitinib, sorafenib, sunitinib, regorafenib
Having joined in other clinical trials within 4 weeks
Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.)
Having haemorrhage history, ≥ Grade Ⅲ (NCI CTCAE 4.0 ) haemorrhage occurred within 4 weeks before screening
Known central nervous system (CNS) metastasis or having CNS metastasis history before screening. CT or MRI scan should be received 28 days before randomization when CNS metastases is clinically suspected
Uncontrolled hypertension with single medical therapy (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg), History of unstable angina pectoris or newly diagnosed unstable angina pectoris within 3 months before screening, myocardial infarction events within 6 months before screening, Arrhythmias (QTcF: ≥450ms in male, ≥ 470ms in female) needed long-term treatment of drugs, ≥ class II cardiac insufficiency by New York Heart Association (NYHA) classification
urinary protein ≥ ++ or 24-hour urinary protein ≥ 1.0 g
Chronic untreated wounds or fractures
Tumor invasion around major vessels shown by imaging, high risk of major vascular invasion leading to massive hemorrhage judged by investigators
Abnormal international normalized ratio (INR) of patients with coagulation dysfunction and hemorrhagic tendency at 14 days before randomization. Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues. However, low doses of warfarin (1mg orally, once daily) or aspirin (between 80mg to 100mg daily) can be used for prevention on the premise of INR ≤ 1.5
Artery/venous thromboembolic events occurred within 1 year before screening, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis (except for recovered venous thrombosis judged by investigators, which was caused by venous catheter in previous chemotherapy) and pulmonary embolism, etc.
All female patients who are not surgically sterilized or postmenopausal refusing to take a reliable method of birth control during the study and within 6 months after the last dose of test article. All female patients in breastfeeding period or in child-bearing period with a positive urine or serum pregnancy test result before randomization. All male subjects who are not surgically sterilized refusing to take a reliable method of birth control during the study and within 6 months after the last dose of test article.
Preexisted thyroid dysfunction, thyroid function cannot be controlled within normal range even using medical therapy
History of psychiatric drug abuse and addiction, dysphrenia
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Jiangsu HengRui Medicine Co., Ltd.lead

Study Sites (44)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Cancer Hospital, Peking University