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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Metastatic Renal Cell Cancer; Renal Cell Cancer

Treatments: Drug: Sunitinib; Drug: Famitinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01829841

FMTN-II-MRCC

Details and patient eligibility

About

• 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Famitinib

Experimental group

Description:

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.

Treatment:

Drug: Famitinib

Sunitinib

Active Comparator group

Description:

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.

Treatment:

Drug: Sunitinib