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Phase II escalation study of sorafenib in patients with advanced renal cell carcinoma who progressed after routine dosage of sorafenib

Phase II escalation study of sorafenib in patients with advanced renal cell carcinoma who progressed after routine dosage of sorafenib

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-12002088
Enrollment
Unknown
Registered
2012-04-06
Start date
2011-04-06
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cell carcinoma

Interventions

1:sorafenib 600mg p.o bid
2:sunitinib 50mg p.o qd
3:Everolimus 10mg p.o qd
4:Everolimus 10mg p.o qd

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. all patients with histologically confirmed RCC that was metastatic or unresectable and measurable according to Response Evaluation Criteria in Solid Tumors(RECIST1.0); 2. patients who was treated with routine dosage of sorafenib but failed; 3. male or female, age 18-75; 4. Patients were required to have an Eastern Cooperative Oncology Group performance status (ECOGPS) of =1.5*10^9/L, platelet count >=100*10^9/L, creatinine <=upper limit of normal, and total bilirubin <=1.5*upper limit of normal.

Exclusion criteria

Exclusion criteria: 1. have been treated with anti-angiogenic therapy other than sorafenib; 2. With other malignancies (except cured basal cell skin cancer or Cervical carcinoma in situ); 3. factors which will influence oral taking of drugs, for example: bad compliance, chronic diarrhea; 4. With other serious diseases, such as: unstable heart disease, severe cerebral vascular disease; 5. severe neurological or phycological disorders; 6. Other anti-tumor treatment or drugs applied simultaneously.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
overall survival;Objective response rate;Disease control rate;Adverse drug reaction;Quality of life;

Countries

China

Contacts

Public ContactYe Dingwei
dwyeli@yahoo.com.cn+86 13701663571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026