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Colorectal Cancer MetastaticPhase 3FACTNCT02390947

Safety and Efficacy Study of Famitinib in Patients With Advanced Colorectal Adenocarcinoma（FACT）

A Phase 3 study testing Famitinib in people with Colorectal Cancer Metastatic and Colorectal Cancer Recurrent, run by Jiangsu HengRui Medicine Co., Ltd. at 44 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Famitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
543 participants
Where
44 sitesChina
Study dates
Jan 2015to Jul 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 )
  • Neutrophils > 1.5×10^9/L
  • Platelets > 100×10^9/L
  • Blood biochemistry:
  • Total bilirubin < 1.25×the upper limit of normal (ULN)
  • Serum transaminase ≤ 2×ULN (≤ 5×ULN, If existing liver metastases)
  • Creatinine clearance rate ≥ 60ml/min (Cockcroft-Gault Formula)
  • C.Doppler echocardiography assessment: Left ventricular ejection fraction (LVEF) ≥ 50%
  • Having recovered from impairments of other therapy before taking research drugs (more than 6 weeks from the last treatment of Nitroso or MMC, more than 4 weeks from the last treatment of other cytotoxic drugs, targeted drugs, radiotherapy or operation, with completely healed wound, more than 2 weeks from the last treatment of Chinese traditional and patent medicine)
  • Signed and dated informed consent
  • Good compliance of patients and agreement of their family members to cooperate on the follow-up of survival.

Who cannot join

  • 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
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  • 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
  • Symptomatic pleural effusion, hydropericardium or ascites needed clinical intervention or being stable less than 4 weeks.
  • History of Immunodeficiency, acquired or congenital immunodeficiency, history of organ transplantation
  • Known active HBV or HCV infection companion with hepatic dysfunction
  • Concomitant disease judged by investigators that may bring serious harm to the safety of patients or the completion of this study

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

China44 sites

  • Beijing Cancer Hospital, Peking University

    Beijing, Beijing Municipality

  • Beijing Chao-yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Chinese Academy of Medical Sciences Cancer Hospital

    Beijing, Beijing Municipality

  • PLA Hospital 301

    Beijing, Beijing Municipality

  • Cancer Hospital of Jilin province

    Changchun, Jilin

  • The First Affiliated Hospital of Jilin University

    Changchun, Jilin

  • Cancer Hospital of Hunan Province

    Changsha, Hunan

  • The Third Xiangya Hospital of Cental South University

    Changsha, Hunan

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu

  • The Third Affiliated Hospital of The Third Military Medical University

    Chongqing, Chongqing Municipality

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Cancer center, Sun Yet-sen University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guangzhou Medical University of Chinese Medicine

    Guangzhou, Guangdong

  • Hainan General Hospital

    Hainan, Hainan

  • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

  • Cancer Hospital of Yunnan Province

    Kunming, Yunnan

  • Cancer Hospital of Jiangxi Province

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Cancer Hospital of Jiangsu Province

    Nanjing, Jiangsu

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Cancer Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality

  • Ruijin Hospital, Shanghai jiaotong University, School of Medicine

    Shanghai, Shanghai Municipality

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • Zhongshan Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Cancer Hospital of Liaoning Province

    Shenyang, Liaoning

  • Chinese Medical University First Hospital

    Shenyang, Liaoning

  • Cancer Hospital of Tianjin City

    Tianjin, Tianjin Municipality

  • People's Hospital of Tianjin City

    Tianjin, Tianjin Municipality

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuhan General Hospital of Guangzhou Military

    Wuhan, Hubei

  • Cancer Hospital of Shanxi Province

    Xian, Shanxi

  • Tangdu Hospital of The Fouth Military Medical University

    Xian, Shanxi

  • The first affiliated hospital of Xinxiang medical university

    Xinxiang, Henan

  • The Affiliated Hospital of Xuzhou Medical Collage

    Xuzhou, Jiangsu

  • Cancer Hospital of Henan Province

    Zhengzhou, Henan

  • The First affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multicenter，Randomized, Double-blind, Placebo-controlled Trial of Famitinib in Patients With Advanced Colorectal Adenocarcinoma

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.

Being tested
Famitinib, Placebo
Keywords
Colorectal Cancer, Famitinib
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FamitinibDrug

    25 mg p.o. qd

  • PlaceboDrug

    25 mg p.o. qd

Study groups in NCT02390947
Study groupRoleWhat they receive
Famitinib armsExperimentalFamitinib 25 mg p.o. qd and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Famitinib
Control armsPlacebo comparatorPlacebo 25 mg p.o. qd and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival(OS)

    Measured: 3 years

Secondary outcomes (6)

  1. Progression Free Survival(PFS)

    Measured: 1.5 years

  2. Objective response rate(ORR)

    Measured: 6 months

  3. Disease Control Rate(DCR)

    Measured: 1.5 years

  4. Quality of Life as measured by EORTC QLQ-C30(3.0)

    Measured: 1.5 years

  5. The incidence of Adverse Events

    Measured: 3 years

  6. The severity of Adverse Events

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2019
  4. Study completionJul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02390947
Sponsor's protocol ID
HR-FMTN-CRC-FACT
Acronym
FACT
Status last verified
May 2017
First submitted
26 Feb 2015
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Famitinib in people with Colorectal Cancer Metastatic and Colorectal Cancer Recurrent, run by Jiangsu HengRui Medicine Co., Ltd. at 44 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival(OS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02390947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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