Clinical trial NCT00586495: Long-term Extension From RCC Phase II (11515)
Official title: Extension Study for BAY43-9006 in Japanese Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Sorafenib
Nexavar
Metastatic RCC
Renal Cell Carcinoma
Unresectable RCC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).


Eligibility criteria: Inclusion Criteria:

Patients are classified into two groups as below at transition date from Study 11515 to this study.

Population I: Patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.

Population II: Patients who have been monitored only for survival status at the end of Study 11515.

Population 1

1. Patients who are willing to continue the study drug,
2. Patients for whom the investigator consider continuation of the study drug is appropriate
3. Patients who do not meet the criteria of removal from the study in Study 11515 at the end of Study 11515.
4. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Population 2

1. Patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

1. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
2. Any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study
3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must use adequate birth control.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Secondary outcomes:
measure: Best Tumor Response
timeFrame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
measure: Overall Survival (OS)
timeFrame: From start of treatment of the first subject until 45 months later, assessed every 3 months
measure: Overall Response Duration
timeFrame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
measure: Time to Objective Response
timeFrame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
measure: Overall Disease Control
timeFrame: From start of treatment of the first subject until 45 months later, assessed every 8 weeks
Other outcomes:
Locations:
city: Asahi
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Kurume
country: Japan
state: Fukuoka
city: Isesaki
country: Japan
state: Gunma
city: Maebashi
country: Japan
state: Gunma
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Sunagawa
country: Japan
state: Hokkaido
city: Tsukuba
country: Japan
state: Ibaraki
city: Morioka
country: Japan
state: Iwate
city: Tsu
country: Japan
state: Mie
city: Natori
country: Japan
state: Miyagi
city: Kashihara
country: Japan
state: Nara
city: Kurashiki
country: Japan
state: Okayama
city: Osakasayama
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Hidaka
country: Japan
state: Saitama
city: Irima-gun
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Hamamatsu
country: Japan
state: Shizuoka
city: Sunto
country: Japan
state: Shizuoka
city: Utsunomiya
country: Japan
state: Tochigi
city: Arakawa-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Ube
country: Japan
state: Yamaguchi
city: Akita
country: Japan
city: Chiba
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Kagoshima
country: Japan
city: Kyoto
country: Japan
city: Kyoto
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Tokushima
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Naito S, Tsukamoto T, Murai M, Fukino K, Akaza H. Overall survival and good tolerability of long-term use of sorafenib after cytokine treatment: final results of a phase II trial of sorafenib in Japanese patients with metastatic renal cell carcinoma. BJU Int. 2011 Dec;108(11):1813-9. doi: 10.1111/j.1464-410X.2011.10281.x. Epub 2011 Apr 11.