Efficacy and Safety of Sorafenib in Advanced Renal Cell Carcinoma (RCC)

NCT00478114 | Completed Phase 3

• 1 other identifier: 12750
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This is the early access programme (EAP) of sorafenib in the indication of advanced renal cell carcinoma (RCC). The study is to evaluate the efficacy and safety of sorafenib in patients with advanced RCC.

Conditions

Renal Cell Carcinoma

Keywords

Renal Cell Carcinoma; Sorafenib

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC

  two years

Secondary Outcomes (1)

• To evaluate the safety (all drug-related adverse events, all adverse events NCI CTCAE 3.0 Grade 3 or higher) of sorafenib in patients with advanced RCC

  two years

Study Arms (1)

1

EXPERIMENTAL

Sorafenib

Drug: sorafenib

Interventions

sorafenib DRUG

sorafenib in the patients with advanced Renal Cell Carcinoma

Also known as: nexavar

1

Eligibility Criteria

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

You may qualify if:

• Written informed consent prior to receiving sorafenib.
• At least 18 years of age.
• Advanced Renal Cell Carcinoma.
• A patient who has received prior systemic and local therapies, must have completely recovered from acute toxicity (i.e. resolved back to CTC-AE Grade 1 or less).
• For patients, who have had major surgery or injury, the wound must be completely healed prior to receiving sorafenib treatment (4 weeks).
• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men must use adequate birth control for at least 3 months after the last administration of sorafenib. Should a woman become pregnant while participating or while the partner of a patient is participating in the study, they should inform their treating physician immediately.

You may not qualify if:

• Pregnant or breastfeeding women.
• Patients with metastatic brain or meningeal tumours.
• Cardiac disease: greater than NYHA functional class II; unstable CAD; MI within the last 6 months.
• HIV infection or chronic hepatitis B or C; patients with Child-Pugh class C hepatic impairment.
• Patients with severe renal impairment (calculated creatinine clearance of \< 30 ml/min) or who require dialysis.
• Patients with active uncontrolled hypertension.
• Patients with recent or active bleeding diathesis.
• Patients with any medical condition which could jeopardize their safety while taking an investigational drug.
• Excluded therapies or medications, previous and concomitant:
• Bone marrow transplant or stem cell rescue within 4 months of study entry.
• Anticipation of the need for major surgery during the course of the study.
• CYP 3A4 inducers (e.g. rifampicin, St. John's Wort \[Hypericum perforatum\], phenytoin, phenobarbital and dexamethasone).
• Any investigational therapy while on this protocol or within 30 days prior to their first dose of sorafenib.
• Any drugs (licensed or investigational) that targets angiogenesis, especially VEGF or VEGF-Receptors (e.g. bevacizumab).
• Any drug (licensed or investigational) that targets Ras-pathway or EGFR.

Sponsors & Collaborators

• Mahidol University: lead
• Bayer: collaborator

Study Sites (1)

Siriraj Hospital, Department of Medicine

Bangkoknoi, Bangkok, 10700, Thailand

Location

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 Officials

• Vichien Srimuninnimit, Ass.Prof.

  Siriraj Hospital, Bangkok, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2010
• Last Updated: August 29, 2011

Record last verified: 2011-08

Locations

TH (1)