Second Line Sorafenib After Pazopanib in Patients With RCC

NCT02122003 | Terminated Phase 2

• 2 other identifiers: GP2Istituto Tumori Milano
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Renal Cell Carcinoma

Keywords

sorafenib; pazopanib; cross-resistance; TKI; mRCC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (months) of patients treated with sorafenib after progression to pazopanib

  24 months

Secondary Outcomes (3)

• Safety profile of sorafenib using Common Terminology Criteria for Adverse Events (CTCAE) criteria v.4.0 in patients previously treated with pazopanib

  24 months

• Overall Survival (months) of patients treated with sorafenib after pazopanib progression

  24 months

• Quality of Life of patients treated with sorafenib after pazopanib progression using the specific questionnaires FKSI-19 and European Organization for Research and Treatment of Cancer quality of life questionnaire -C30.

  24 months

Study Arms (1)

sorafenib

EXPERIMENTAL

Sorafenib 400 mg bid

Drug: Sorafenib

Interventions

Sorafenib DRUG

Sorafenib 400 mg bid

Also known as: Nexavar

sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Istituto Tumori

Milan, Mi, 20156, Italy

Location

Related Publications (1)

• Iacovelli R, Verzoni E, Grassi P, Farcomeni A, de Braud F, Procopio G. Rationale and protocol of SOAP: a phase II study to evaluate the efficacy of sorafenib as second-line treatment after pazopanib in patients with advanced renal cell carcinoma. Tumori. 2014 Nov-Dec;100(6):e282-5. doi: 10.1700/1778.19296.

  PMID: 25688511 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2014
• First Posted: April 24, 2014
• Study Start: September 1, 2016
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: November 22, 2017

Record last verified: 2017-11

Locations

IT (1)