Completed

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

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What is being tested

Famitinib

+ Sunitinib

Drug
Who is being recruted

Urogenital Diseases+13

+ Adenocarcinoma

+ Carcinoma

From 18 to 75 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2011
See protocol details

Summary

Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: May 3, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01829841
Principal SponsorJiangsu HengRui Medicine Co., Ltd.
Last updated: May 3, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAdenocarcinomaCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal Cell

Criteria

9 inclusion criteria required to participate
ECOG 0-1
First-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients)
Life expectancy >= 3 months
Male or female, age >= 18 and <= 75
Show More Criteria
13 exclusion criteria prevent from participating
A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
Coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy
History of immunodeficiency, including HIV testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation
Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cancer Institute and Hospital Chinese Academy of Medical Sciences

Beijing, ChinaOpen Cancer Institute and Hospital Chinese Academy of Medical Sciences in Google Maps
CompletedOne Study Center