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

NCT01829841 | Completed Phase 2 DMC

• 1 other identifier: FMTN-II-MRCC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Cancer; Metastatic Renal Cell Cancer

Keywords

MRCC; Metastatic Renal Cell Cancer; Famitinib; Sunitinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  18 weeks

Secondary Outcomes (5)

• Progress free survival (PFS)

  3 years

• Disease Control Rate (DCR)

  3 years

• Overall Survival (OS)

  3 years

• Quality of Life

  42-day cycle visit until disease progress

• Number of Participants with Adverse Events as a Measure of Safety

  3 years

Other Outcomes (1)

• body vitals, laboratory parameters

  3 years

Study Arms (2)

Famitinib

EXPERIMENTAL

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

Sunitinib

ACTIVE COMPARATOR

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

Interventions

Famitinib DRUG

Famitinib 25 mg p.o. qd

Famitinib

Sunitinib DRUG

Sunitinib 50 mg p.o. qd

Sunitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Cancer Institute and Hospital Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

famitinib; Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 11, 2013
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2016
• Last Updated: May 3, 2018

Record last verified: 2013-04

Locations

CN (1)