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 | Status | |
|---|---|---|
Locations Sapporo City General Hospital Sapporo, Japan, 060-8604 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido Cancer Center Sapporo, Japan, 003-0804 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunagawa City Medical Center Sunagawa, Japan, 073-0196 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akita University Hospital Akita, Japan, 010-8543 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Central Hospital Tokyo, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Keio University Hospital Tokyo, Japan, 160-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Hospital Tokyo, Japan, 162-8666 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nippon Medical School Hospital Tokyo, Japan, 113-8603 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Women's Medical University Medical Center East Tokyo, Japan, 116-8567 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba Cancer Center Chiba, Japan, 260-0801 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba University Hospital Chiba, Japan, 260-8677 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Medical School Hospital Irima-gun, Japan, 350-0495 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Isesaki Municipal Hospital Isesaski, Japan, 372-0817 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tochigi Cancer Center Utsunomiya, Japan, 320-0834 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tsukuba University Hospital Tsukuba, Japan, 305-8576 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sapporo Medical University Hospital Sapporo, Japan, 060-8543 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Iwate Medical University Hospital Morioka, Japan, 020-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tohoku University Hospital Sendai, Japan, 980-8574 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Miyagi Cancer Center Natori, Japan, 981-1293 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamagata University Hospital Yamagata, Japan, 990-9585 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Tokyo Hospital Tokyo, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teikyo University Hospital Tokyo, Japan, 173-0003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asahi Central Hospital Asahi, Japan, 289-2511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Defense Medical College Hospital Tokorozawa, Japan, 359-8513 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gunma University Hospital Maebashi, Japan, 371-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagoya University Hospital Nagoya, Japan, 466-8560 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Niigata University Medical and Dental Hospital Niigata, Japan, 951-8520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto Medical University Hospital Kyoto, Japan, 602-8566 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hamamatsu University Hospital Hamamatsu, Japan, 431-3192 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Cancer Center Sunto, Japan, 411-8777 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Yamanashi Hospital Nakakoma, Japan, 409-3898 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Medical Center for Cancer and Cardiovascular Diseases Osaka, Japan, 537-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kinki University Hospital Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyoto University Hospital Kyoto, Japan, 606-8507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mie University Hospital Tsu, Japan, 514-8507 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurashiki Central Hospital Kurashiki, Japan, 710-8602 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Yamaguchi University Hospital Ube, Japan, 755-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokushima University Hospital Tokushima, Japan, 770-8503 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagawa University Hospital Kita, Japan, 761-0793 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Harasanshin Hospital Fukuoka, Japan, 812-0033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kurume University Hospital Kurume, Japan, 830-0011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nagasaki University Hospital Nagasaki, Japan, 852-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Japanese Red Cross Wakayama Medical center Wakayama, Japan, 640-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wakayama Medical University Hospital Wakayama, Japan, 641-8510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Okayama University Hospital Okayama, Japan, 700-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shikoku Cancer Center Matsuyama, Japan, 791-0280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kagoshima University Hospital Kagoshima, Japan, 890-8520 | Status Completed | 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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