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Colorectal CancerPhase 2NCT01762293

A Study of Famitinib in Patients With Advanced Colorectal Cancer

A Phase 2 study testing Famitinib in people with Colorectal Cancer and Colorectal Cancer Metastatic, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Completed

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

Official record
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Trial summary

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the toxicity is manageable. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Famitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
2 sitesChina
Study dates
Apr 2012to Oct 2014
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologic confirmed recurrent and/or metastatic CRC and previously received at least two lines of standard therapy failure(must include 5-Fu,irinotecan and oxaliplatin)
  • At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
  • age ≥ 18 and ≤ 70
  • ECOG 0-1
  • Life expectancy of more than 3 months
  • More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors
  • Signed and dated informed consent
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

  • Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit(e.g sorafenib,sunitinib,regorafenib)
  • Any factors that influence the usage of oral administration
  • Having obvious gastrointestinal hemorrhagic tendency
  • Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
  • Organ tumor overloading
Show all 20Show fewer
  • Inadequate hepatic, renal, heart, and hematologic functions (hemoglobin ≤ 90g/L, platelets ≤ 100×10^9/L, neutrophils ≤ 1.5×10^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), and serum transaminase ≥ 1.5×ULN (If liver metastases, serum transaminase≥ 2.5×ULN), creatinine clearance rate ≤ 60ml/min, cholesterol ≥ 1.5×ULN and triglyceride≥ 2.5 x ULN, LVEF: < 50%
  • Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency
  • urinary protein≥ ++ or 24-hour urinary protein ≥ 1.0 g
  • Long-term untreated wounds or fractures
  • Blood coagulation abnormal, having hemorrhagic tendency
  • Within 1 year before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
  • Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) or low-dose aspirin (between 80mg to 100mg daily) is allowed
  • Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
  • Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
  • Abuse of psychiatric drugs or dysphrenia
  • Less than 4 weeks from the last clinical trial
  • Ascites need treatment
  • Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
  • Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Cancer Hospital, Peking University

    Beijing

  • Cancer center, Sun Yet-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter, Phase IIb Study of Famitinib as Third Line Treatment in Patients With Advanced Colorectal Cancer

Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3, and it's anti-angiogenesis effect has been viewed in preclinical tests. Phase I study has shown that the toxicity is manageable.

The purpose of this study is to determine whether Famitinib can improve progression free survival compared with placebo in patients with advanced colorectal cancer who failed in previous at least two lines of chemotherapy.

Being tested
Famitinib, placebo
Keywords
CRC, Famitinib, Phase II, Colorectal Cancer
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

    Famitinib 25 mg p.o. qd

  • placeboOther

    p.o. qd

Study groups in NCT01762293
Study groupRoleWhat they receive
FamitinibExperimentalFamitinib 25 mg qd p.o. and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Drug: Famitinib
PlaceboPlacebo comparatorPlacebo qd p.o., and the medication continued until disease progression or intolerable toxicity or patients withdrawal of consent
Receives: Other: placebo

What is being measured

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

  1. Progression Free Survival(PFS)

    Measured: 3 years

Secondary outcomes (5)

  1. Objective response rate(ORR)

    Measured: 12 weeks

  2. Disease Control Rate(DCR)

    Measured: 12 weeks

  3. Overall Survival(OS)

    Measured: 3 years

  4. Quality of Life

    Measured: 42-day cycle visit until disease progress

  5. Number of Participants with Adverse Events as a Measure of Safety

    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 posted7 Jan 2013 (estimated)
  2. Study startApr 2012
  3. Primary completionSep 2014
  4. Study completionOct 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01762293
Sponsor's protocol ID
FMTN-IIb-CRC
Status last verified
Jan 2013
First submitted
4 Jan 2013
Last updated
18 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Xu RH, Shen L, Wang KM, Wu G, Shi CM, Ding KF, Lin LZ, Wang JW, Xiong JP, Wu CP, Li J, Liu YP, Wang D, Ba Y, Feng JP, Bai YX, Bi JW, Ma LW, Lei J, Yang Q, Yu H. Famitinib versus placebo in the treatment of refractory metastatic colorectal cancer: a multicenter, randomized, double-blinded, placebo-controlled, phase II clinical trial. Chin J Cancer. 2017 Dec 22;36(1):97. doi: 10.1186/s40880-017-0263-y.

    PubMed 29273089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Famitinib in people with Colorectal Cancer and Colorectal Cancer Metastatic, run by Jiangsu HengRui Medicine Co., Ltd. at 2 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 8 inclusion and 20 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Progression Free Survival(PFS) (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 NCT01762293, which also lists 1 linked publication.

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 18 Apr 2018.

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