Clinical trial NCT00661375: BAY43-9006 Phase II Study for Renal Cell Carcinoma
Official title: Phase II Study of BAY 43-9006 in Japanese Patients With Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: BAY 43-9006
Phase II
Renal cell carcinoma
Response rate
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 131
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: To evaluate efficacy, safety, and pharmacokinetics of BAY 43-9006 in patients with unresectable and/or metastatic renal cell cancer (RCC) who have failed at least one cytokine containing regimen.


Eligibility criteria: Inclusion Criteria:

* Patients who suffer from unresectable and/or metastatic, measurable RCC histologically or cytologically documented.
* Patients with rare subtypes of RCC, such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors, are excluded from study participation.

Exclusion Criteria:

* More than three regimens of previous treatment for RCC

Primary outcomes:
measure: Tumor response rate
timeFrame: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
Secondary outcomes:
measure: Time to progression
timeFrame: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
measure: Proportion of patients with CR and PR according to the criteria of General Rule for Clinical and Pathological Studies on Renal Cell carcinomaCR and PR rate according to General Rule for Clinical and Pathological Studies on Renal Cell carcinoma
timeFrame: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
measure: Time to death
timeFrame: At the time of death
measure: Overall response duration and time to objective response
timeFrame: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
measure: Overall disease control rate
timeFrame: Tumor measurements: every 6 weeks for the first 24 weeks (or the time of evaluation as progression, whichever is earlier) and every 8 weeks thereafter.
measure: FACT-G and FKSI
timeFrame: Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter.
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Asahi
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Kurume
country: Japan
state: Fukuoka
city: Isesaski
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: Sapporo
country: Japan
state: Hokkaido
city: Sunagawa
country: Japan
state: Hokkaido
city: Tsukuba
country: Japan
state: Ibaraki
city: Morioka
country: Japan
state: Iwate
city: Kita
country: Japan
state: Kagawa
city: Tsu
country: Japan
state: Mie
city: Natori
country: Japan
state: Miyagi
city: Sendai
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: 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: Ube
country: Japan
state: Yamaguchi
city: Nakakoma
country: Japan
state: Yamanashi
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: Nagasaki
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Tokushima
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Tokyo
country: Japan
city: Wakayama
country: Japan
city: Wakayama
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.
citation: Iijima M, Fukino K, Adachi M, Tsukamoto T, Murai M, Naito S, Minami H, Furuse J, Akaza H. Sorafenib-associated hand-foot syndrome in Japanese patients. J Dermatol. 2011 Mar;38(3):261-6. doi: 10.1111/j.1346-8138.2010.01059.x. Epub 2010 Nov 2.
citation: Akaza H, Tsukamoto T, Murai M, Nakajima K, Naito S. Phase II study to investigate the efficacy, safety, and pharmacokinetics of sorafenib in Japanese patients with advanced renal cell carcinoma. Jpn J Clin Oncol. 2007 Oct;37(10):755-62. doi: 10.1093/jjco/hym095. Epub 2007 Oct 19.
citation: Katakami N, Inaba Y, Sugata S, Tsurusaki M, Itoh T, Machida T, Tanaka H, Nakayama T, Morikawa T, Breuer J, Aitoku Y. Magnetic resonance evaluation of brain metastases from systemic malignances with two doses of gadobutrol 1.0 m compared with gadoteridol: a multicenter, phase ii/iii study in patients with known or suspected brain metastases. Invest Radiol. 2011 Jul;46(7):411-8. doi: 10.1097/RLI.0b013e3182145a6c.