Trial Condition(s):
Carcinoma, Renal Cell
Sorafenib Dose Escalation in Renal Cell Carcinoma
Bayer Identifier:
12913
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors.
This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient’s tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient’s treatment, as long as the patient is not experiencing side effects and the patient’s tumor has not grown.
Inclusion Criteria
- Age > 18 years. - Metastatic clear cell RCC (renal cell carcinoma) - Subjects with at least one uni-dimensional measurable lesion. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Memorial Sloan Kettering Cancer Center (MSKCC) good or intermediate category - 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 treatment - Signed informed consent must be obtained prior to any study specific procedures. - Subjects must have received no prior systemic anticancer therapy for the treatment of their renal cell carcinoma - Prior total nephrectomy
Exclusion Criteria
- History of cardiac disease - History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C - Active clinically serious infections (> grade 2 National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 3.0) - Symptomatic metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry. - Subjects with evidence or history of bleeding diathesis - Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of treatment. - Delayed healing of wounds, ulcers or bone fractures - Subjects with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range by medication - Subjects undergoing renal dialysis - Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to 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 three months after the completion of trial. - Prior adjuvant sorafenib is excluded. - Radiotherapy during study or within 3 weeks of start of study drug - Major surgery within 4 weeks of start of study - Investigational drug therapy outside of this trial during or within 4 weeks of study entry
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Eberhard-Karls-Universität Tübingen Tübingen, Germany, 72076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Greater Manchester, United Kingdom, M20 4BX | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beatson West of Scotland Cancer Centre Glasgow, United Kingdom, G12 0YN | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Velindre Hospital Cardiff, United Kingdom, CF14 7TB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13385 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Saint André - Bordeaux BORDEAUX, France, 33000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Départemental-La Roche sur Yon LA ROCHE SUR YON, France, 85925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego Wroclaw, Poland, 50 - 556 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Nazionale Tumori Milano, Italy, 20133 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Friedrich-Schiller-Universität Jena Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Bretonneau - Tours TOURS, France, 37044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau - Nantes NANTES, France, 44805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Saint Louis - Paris PARIS CEDEX 10, France, 75475 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wojskowy Instytut Medyczny Warszawa, Poland, 04-141 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NZOZ ONKO-MED Olsztyn, Poland, 10-226 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Centro di Riferimento Oncologico - CRO Aviano, Italy, 33081 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Best Response - mITT (modified intent-to-treat) populationTimeframe: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.
- Tumor Response - ITT (intent to treat) populationTimeframe: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.
Secondary Outcome
- Pharmacokinetics (PK) analysis – Area under the drug concentration-time curve from time zero to 10 hours postdose (AUC(0-10),ss)Timeframe: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8 and 10 hours post-dose.
- Pharmacokinetics (PK) analysis – Area under the drug concentration-time curve from time zero to 12 hours postdose (AUC(0-12),ss)Timeframe: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.
- Pharmacokinetics (PK) analysis – Maximum observed concentration in plasma (Cmax)Timeframe: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.
- Pharmacokinetics (PK) analysis – Time to maximum concentration (Tmax)Timeframe: Blood samples were collected at screening (blank) and on day 28 of the first cycle completed at each dose level. Samples were drawn at the following time points in relation to morning dose of sorafenib: pre-dose, 2, 4, 6, 8, 10 and 12 hours post-dose.
- Progression-free Survival (PFS)Timeframe: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.
- Time to Progression (TTP)Timeframe: Radiological assessments were performed every 8 weeks (2 cycles) from start of the treatment. After completion of 6 cycles of treatment at the highest tolerated dose level, assessments were performed every 12 weeks for up to 34 months.
Additional Information
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