check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

12913

ClinicalTrials.gov Identifier:

NCT00618982

EudraCT Number:

2007-004875-21

EU CT Number:

Not Available
Sorafenib Dose Escalation in Renal Cell Carcinoma

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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
83
Trial Dates
February 2008 - January 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Terminated
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Terminated
Universitätsklinik Gießen und Marburg GmbHMarburg, 35043, Germany
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Christie HospitalGreater Manchester, M20 4BX, United Kingdom
Completed
Beatson West of Scotland Cancer CentreGlasgow, G12 0YN, United Kingdom
Completed
Velindre HospitalCardiff, CF14 7TB, United Kingdom
Completed
Hôpital de la Timone - MarseilleMARSEILLE, 13385, France
Completed
Hôpital Saint André - BordeauxBORDEAUX, 33000, France
Completed
Centre Hospitalier Départemental-La Roche sur YonLA ROCHE SUR YON, 85925, France
Completed
Centrum Onkologii - Instytut im. M.Sklodowskiej-CurieWarszawa, 02-781, Poland
Terminated
Uniwersytecki Szpital Kliniczny im. J. Mikulicza-RadeckiegoWroclaw, 50 - 556, Poland
Completed
IRCCS Istituto Nazionale TumoriMilano, 20133, Italy
Completed
Klinikum der Friedrich-Schiller-Universität JenaJena, 07740, Germany
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Completed
Hôpital Bretonneau - ToursTOURS, 37044, France
Completed
Centre René Gauducheau - NantesNANTES, 44805, France
Completed
Hôpital Saint Louis - ParisPARIS CEDEX 10, 75475, France
Completed
Wojskowy Instytut MedycznyWarszawa, 04-141, Poland
Completed
NZOZ ONKO-MEDOlsztyn, 10-226, Poland
Completed
IRCCS Centro di Riferimento Oncologico - CROAviano, 33081, Italy
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy

Primary Outcome

  • Best Response - mITT (modified intent-to-treat) population
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Tumor Response - ITT (intent to treat) population
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Pharmacokinetics (PK) analysis – Area under the drug concentration-time curve from time zero to 10 hours postdose (AUC(0-10),ss)
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics (PK) analysis – Area under the drug concentration-time curve from time zero to 12 hours postdose (AUC(0-12),ss)
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics (PK) analysis – Maximum observed concentration in plasma (Cmax)
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics (PK) analysis – Time to maximum concentration (Tmax)
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free Survival (PFS)
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression (TTP)
    date_rangeTime Frame:
    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.
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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