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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829841
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Metastatic Renal Cell Cancer Drug: Famitinib Drug: Sunitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Famitinib
Famitinib 25 mg qd p.o., 6 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
Drug: Famitinib
Famitinib 25 mg p.o. qd

Active Comparator: Sunitinib
Sunitinib 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.
Drug: Sunitinib
Sunitinib 50 mg p.o. qd




Primary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Progress free survival (PFS) [ Time Frame: 3 years ]
  2. Disease Control Rate (DCR) [ Time Frame: 3 years ]
  3. Overall Survival (OS) [ Time Frame: 3 years ]
  4. Quality of Life [ Time Frame: 42-day cycle visit until disease progress ]
  5. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ]

Other Outcome Measures:
  1. body vitals, laboratory parameters [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829841


Locations
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China
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Study Chair: Jinwan Wang, M.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Chair: Jianhui Ma, M.D Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT01829841    
Other Study ID Numbers: FMTN-II-MRCC
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2013
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
MRCC
Metastatic Renal Cell Cancer
Famitinib
Sunitinib
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action