Second Line Sorafenib After Pazopanib in Patients With RCC

• Status: Terminated
• Trial end date: 2017-11-08
• Target enrollment: 0
• Participant gender: All

Summary

• Retrospective studies showed Sorafenib's efficacy as second line treatment after a Tyrosine Kinase Inhibitor (TKI).

• Currently there is no standard of treatment in 2nd line for patients treated in first line with pazopanib for metastatic Renal Cell Carcinoma (mRCC).

• With this trial we evaluate the efficacy of sorafenib as second line of treatment in patients treated with pazopanib for mRCC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Patients with histological diagnosis of Renal Cell Carcinoma (RCC)

• Measurable disease

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy of at least 12 weeks.

• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

• Hemoglobin >= 10.0 g/dl

• Absolute neutrophil count (ANC) >1,500/mm3

• Platelet count >= 100,000/ml

• Total bilirubin ≤ 1.5 times the upper limit of normal

• ALT and AST ≤ 2.5 x upper limit of normal

• Alkaline phosphatase ≤ 4 x upper limit of normal

• prothrombin time-international normalized ratio /partial thromboplastin time ≤ 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until international normalized ratio is stable based on a measurement at pre-dose, as defined by the local standard of care.

• Prognosis according to Heng: good or intermediate

• Previous treatment with pazopanib

• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial.

• Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

• First line treatment for metastatic RCC other than pazopanib.

• History of cardiac disease: congestive heart failure >New York Heart Association class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic).

• History of HIV infection

• Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

• Brain or meningeal metastases

• Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)

• History of organ allograft

• Patients with evidence or history of bleeding diathesis

• Patients undergoing renal dialysis