Know Cancer

or
forgot password

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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Renal Cell Cancer, Metastatic Renal Cell Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

18 weeks

Safety Issue:

No

Principal Investigator

Jinwan Wang, M.D

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

FMTN-II-MRCC

NCT ID:

NCT01829841

Start Date:

May 2011

Completion Date:

June 2014

Related Keywords:

  • Renal Cell Cancer
  • Metastatic Renal Cell Cancer
  • MRCC
  • Metastatic Renal Cell Cancer
  • Famitinib
  • Sunitinib
  • Carcinoma, Renal Cell

Name

Location