Trial Condition(s):
Carcinoma, Renal Cell
BAY43-9006 Phase II study for Renal cell carcinoma
Bayer Identifier:
11515
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Sapporo City General Hospital Sapporo, Japan, 060-8604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido Cancer Center Sapporo, Japan, 003-0804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunagawa City Medical Center Sunagawa, Japan, 073-0196 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akita University Hospital Akita, Japan, 010-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Central Hospital Tokyo, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Keio University Hospital Tokyo, Japan, 160-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Hospital Tokyo, Japan, 162-8666 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nippon Medical School Hospital Tokyo, Japan, 113-8603 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Medical Center East Tokyo, Japan, 116-8567 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba Cancer Center Chiba, Japan, 260-0801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba University Hospital Chiba, Japan, 260-8677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Medical School Hospital Irima-gun, Japan, 350-0495 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Isesaki Municipal Hospital Isesaski, Japan, 372-0817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tochigi Cancer Center Utsunomiya, Japan, 320-0834 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tsukuba University Hospital Tsukuba, Japan, 305-8576 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapporo Medical University Hospital Sapporo, Japan, 060-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Iwate Medical University Hospital Morioka, Japan, 020-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tohoku University Hospital Sendai, Japan, 980-8574 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Miyagi Cancer Center Natori, Japan, 981-1293 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamagata University Hospital Yamagata, Japan, 990-9585 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Tokyo Hospital Tokyo, Japan, 113-8655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teikyo University Hospital Tokyo, Japan, 173-0003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asahi Central Hospital Asahi, Japan, 289-2511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Defense Medical College Hospital Tokorozawa, Japan, 359-8513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Niigata University Medical and Dental Hospital Niigata, Japan, 951-8520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto Medical University Hospital Kyoto, Japan, 602-8566 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamamatsu University Hospital Hamamatsu, Japan, 431-3192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Cancer Center Sunto, Japan, 411-8777 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Yamanashi Hospital Nakakoma, Japan, 409-3898 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka, Japan, 537-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kinki University Hospital Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto University Hospital Kyoto, Japan, 606-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mie University Hospital Tsu, Japan, 514-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurashiki Central Hospital Kurashiki, Japan, 710-8602 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamaguchi University Hospital Ube, Japan, 755-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokushima University Hospital Tokushima, Japan, 770-8503 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagawa University Hospital Kita, Japan, 761-0793 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harasanshin Hospital Fukuoka, Japan, 812-0033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagasaki University Hospital Nagasaki, Japan, 852-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Japanese Red Cross Wakayama Medical center Wakayama, Japan, 640-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wakayama Medical University Hospital Wakayama, Japan, 641-8510 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Okayama University Hospital Okayama, Japan, 700-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shikoku Cancer Center Matsuyama, Japan, 791-0280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagoshima University Hospital Kagoshima, Japan, 890-8520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Phase II study of BAY 43-9006 in Japanese patients with Renal cell carcinoma
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Tumor response rateTimeframe: 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 Outcome
- Time to progressionTimeframe: 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.
- 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 carcinomaTimeframe: 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.
- Time to deathTimeframe: At the time of death
- Overall response duration and time to objective responseTimeframe: 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.
- Overall disease control rateTimeframe: 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.
- FACT-G and FKSITimeframe: Screening visit (within -14 days), every 6 weeks for the first 24 weeks and every 8 weeks thereafter.
Additional Information
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