Study of Sorafenib in Patients With Advanced Renal Cell Carcinoma

NCT00848640 | Completed Phase 2 DMC

• 1 other identifier: 12594
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose study is to evaluate the efficacy and safety of Sorafenib as first line treatment for patients - unsuitable for another approved first line therapy - with advanced RCC in the Middle East Region.

Conditions

Metastatic Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• evaluate the efficacy by evaluating the disease control rate (DCR) and safety of Sorafenib for first line patients unsuitable for another approved first line therapy with advanced RCC in the Middle East region.

  Disease Control Rate (DCR) defined as either CR, PR or SD for at least 8 weeks

Secondary Outcomes (1)

• Quality of life of patient with RCC and Progression Free Survival

  One year

Study Arms (1)

Sorafenib

EXPERIMENTAL

Drug: Sorafenib

Interventions

Sorafenib DRUG

400 mg twice daily

Sorafenib

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient must provide written informed consent prior to receiving Sorafenib.
• The male or female patient must be at least 18 years of age.
• The patient must have pathologically proven advanced Renal Cell Carcinoma.
• Only patients with measurable disease (According to RECIST) at baseline should be included in protocol where Disease Control Rate (DCR) is the primary endpoint.
• The patient requires Sorafenib as First line therapy as the patient is unsuitable for another approved first line therapy for advanced RCC.
• The patient must be, in the Investigator's opinion, reasonably likely to benefit from treatment with Sorafenib as a single agent.
• The patient must have an Eastern Cooperative Oncology Group performance status of 0 - 2.
• The patient will not require other systemic anti-cancer chemotherapy, immunotherapy or hormonal therapy, except for bisphosphonates while taking Sorafenib.
• Both male and female patients must use adequate barrier birth control methods during their participation in the protocol. The birth control methods must be used for 4 weeks for female patients and for 3 months for male patients after discontinuation of treatment with Sorafenib.
• For patients, who have had major surgery, the wound must be completely healed prior to receiving Sorafenib treatment (4 weeks).
• The patient must have within normal Renal \& Hepatic function.
• The patient must have within normal CBC.

You may not qualify if:

• Patients who are currently enrolled in or have previously participated in any other Sorafenib trial.
• Suitable or received any other systemic therapy for treatment RCC (IL-2, INF)
• Patients who have a life expectancy of less than 2 months.
• Patients with metastatic brain or meningeal tumours.
• Patients are excluded who require any of the following:
• Investigational drug therapy during the treatment with Sorafenib or within 30 days prior to their first dose of Sorafenib.
• Concomitant Rifampicin.
• Non-measurable disease according to RECIST.
• Concomitant St. John's Wort (Hypericum perforatum).
• Warfarin (or similar medication) is allowed.
• Women who are pregnant or breast-feeding. Women of childbearing potential must have a negative pregnancy test performed within seven days of the start of study drug (please note that no laboratory data are collected in this study).
• Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity)
• Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic; intervention not indicated, palpitations present and QTc \> 0.45 - 0.47 second).
• Patients with active coronary artery disease or ischemia.
• Patients with Child-Pugh class C hepatic impairment.

Sponsors & Collaborators

• Egyptian Foundation For Cancer Research: lead

Study Sites (1)

Egyptian Foundation For Cancer Research

Cairo, 11553, Egypt

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

• Hussein M. Khaled, MD

  Egyptian Foundation For Cancer Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2009
• First Posted: February 20, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: May 26, 2010

Record last verified: 2009-09

Locations

EG (1)