A Phase I/II Study of S-1 in Combination with Sorafenib in Patients with Metastatic Renal Cell Cancer.
Phase 1
- Conditions
- Renal cell cancer
- Registration Number
- JPRN-jRCT2080220941
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
1)Patients with renal cell carcinoma metastases who underwent nephrectomy(with histological confirmation)
2)Patients had not received previous treatment for renal cell carcinoma. Or patients had progressed after one cytokine therapy
Exclusion Criteria
1)Patients with active peptic ulcer
2)Patients with skin disease under medical treatment
3)Patients with uncontrolled hypertension
4)Patients with diarrhea
5)Patients with brain metastases
6)Patients with multiple carcinoma
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy and safety<br>Estimation of MTD and RD in Step 1 and estimation of response rate administered at RD in Step 2.
- Secondary Outcome Measures
Name Time Method Efficacy and safety<br>Adverse events, adverse drug reactions, pharmacokinetics and antitumor effect