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Renal Cell CancerPhase 2NCT01829841

A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer

A Phase 2 study testing Famitinib and Sunitinib in people with Renal Cell Cancer and Metastatic Renal Cell Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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. Phase I study has shown that the toxicity is manageable. The purpose of this study is to compare the efficacy and safety profile between Famitinib and Sunitinib in patients with metastatic renal cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Famitinib and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
May 2011to May 2016
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
  • First-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients)
  • With measurable disease (using RECIST1.0 standard conventional CT scan ≥ 20 mm, spiral CT scan ≥ 10mm, target lesion did not receive radiation therapy, cryotherapy)
  • Male or female, age ≥18 and ≤75
  • ECOG 0-1
  • Life expectancy ≥ 3 months
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  • Subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed
  • Normal major organ function
  • Signed and dated informed consent

Who cannot join

  • Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
  • Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ
  • Participated in other clinical trials within four weeks
  • A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
  • Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
  • Patients with hypertension (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 440ms) and class I heart failure.
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  • Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g
  • Coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy
  • Previous hyperactivity / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism
  • The preexisting abnormal thyroid function, even in the case of medication still can not be maintained within the normal range
  • With a history of abuse of psychotropic drugs or mental disorders
  • Patients with Hepatitis B or Hepatitis C
  • History of immunodeficiency, including HIV testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Institute and Hospital Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

Official title: A Randomized, Positive-controlled, Double-blind, Multicenter, Phase II Study of Famitinib as First/Second Line Treatment in Patients With Advanced Metastatic Renal Cell Cancer

  • Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
  • The purpose of this study is to compare the efficacy and safety profile between Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.
Being tested
Famitinib, Sunitinib
Keywords
MRCC, Metastatic Renal Cell Cancer, Famitinib, Sunitinib
Medical subject headings
Carcinoma, Renal Cell

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

  • SunitinibDrug

    Sunitinib 50 mg p.o. qd

Study groups in NCT01829841
Study groupRoleWhat they receive
FamitinibExperimentalFamitinib 25 mg qd p.o., 6 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Receives: Drug: Famitinib
SunitinibActive comparatorSunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Receives: Drug: Sunitinib

What is being measured

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

  1. Objective Response Rate

    Measured: 18 weeks

Secondary outcomes (5)

  1. Progress free survival (PFS)

    Measured: 3 years

  2. Disease Control Rate (DCR)

    Measured: 3 years

  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 posted11 Apr 2013 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2013
  4. Study completionMay 2016

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
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829841
Sponsor's protocol ID
FMTN-II-MRCC
Status last verified
Apr 2013
First submitted
8 Apr 2013
Last updated
3 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Famitinib and Sunitinib in people with Renal Cell Cancer and Metastatic Renal Cell Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 9 inclusion and 13 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Objective Response Rate (time frame: 18 weeks). 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 NCT01829841.

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 3 May 2018.

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