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Recurrent Nasopharyngeal CarcinomaPhase 2NCT01392235

Famitinib in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

A Phase 2 study testing Famitinib in people with Recurrent Nasopharyngeal Carcinoma and Metastatic Nasopharyngeal Carcinoma, 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

RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable. PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Famitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteChina
Study dates
Jul 2011to Aug 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )
  • Have failed for ≥2 lines of chemotherapy
  • At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
  • ≥ 18 and ≤ 70 years of age
  • ECOG performance scale 0-2
  • Life expectancy of more than 3 months
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  • More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors
  • Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, 24-hour urinary protein ≤ 1.0 g total bilirubin < 1.25×the upper limit of normal(ULN), and serum transaminase < 1.5×the ULN (If liver metastases, serum transaminase< 2.5×the ULN), serum creatine ≤ 1x ULN, creatinine clearance rate > 50ml/min, Cholesterol≤7.75 mmol/L and triglyceride≤2.5 x ULN, LVEF: ≥ 50%
  • Patients could provide 4-6 pieces of organization wax or pathological section
  • 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.
  • Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Who cannot join

  • Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit
  • Prior radiotherapy more than 2 courses
  • Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Less than 4 weeks from the last clinical trial
  • Any factors that influence the usage of oral administration
  • Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
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  • Imageology shows that tumor lesion less than 5 mm to great vessels
  • 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
  • URT: urine protein ≥ ++ and > 1.0 g of 24 h
  • Long-term untreated wounds or fractures
  • Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.
  • Within 6 months before the first treatment occurrs 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
  • Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
  • Abuse of Psychiatric drugs or dysphrenia
  • Viral hepatitis type B or type C
  • 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

1 site in 1 country.

China1 site

  • Department of Medical Oncology, Cancer Center, Sun Yet-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)

RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.

PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC.

Being tested
Famitinib
Keywords
Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

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

  • FamitinibDrug

    25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Study groups in NCT01392235
Study groupRoleWhat they receive
Drug: FamitinibExperimentalNot described
Receives: Drug: Famitinib

What is being measured

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

  1. CBR(Clinical Benefit Rate)

    To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC

    Measured: 12 weeks

Secondary outcomes (6)

  1. ORR (Objective Response Rate)

    Measured: 12 weeks

  2. PFS(Progress Free Survival)

    Measured: 3 years

  3. DCR(Disease Control Rate)

    Measured: 12 weeks

  4. OS(Sverall Survival)

    Measured: 3 years

  5. To evaluate the safety and tolerability

    Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib.

    Measured: 3 years

  6. QoL(Quality of Life)

    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 posted12 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionApr 2015
  4. Study completionAug 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01392235
Sponsor's protocol ID
FMTN-II-NPC
Status last verified
Dec 2018
First submitted
3 Jul 2011
Last updated
22 Jan 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Famitinib in people with Recurrent Nasopharyngeal Carcinoma and Metastatic Nasopharyngeal Carcinoma, 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 11 inclusion and 18 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 Jan 2019. 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?

CBR(Clinical Benefit Rate) (time frame: 12 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 NCT01392235.

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 Jan 2019.

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