Contact information
Type
Scientific
Primary contact
Dr Iwona Skoneczna
ORCID ID
Contact details
Roentgena 5
Warsaw
02781
Poland
+48 (0)22 5462098
i.skoneczna@coi.waw.pl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12602
Study information
Scientific title
Sorafenib (NEXAVAR®) monotherapy in patients with inoperable/recurrent germ cell carcinoma refractory to chemotherapy
Acronym
MRS
Study hypothesis
Sorafenib prolongs Progression-Free Survival (PFS) in patients with inoperable/recurrent germ cell carcinoma refrectory to chemotherapy.
Ethics approval
Submitted, not reviewed yet as of 06/12/2007.
Study design
Single arm, non-randomised, single institution, phase II trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Testicular cancer
Intervention
There is only one treatment arm, therefore all participants will receive sorafenib 400 mg (2 tablets of 200 mg twice daily orally) continuously in 4-week cycles till progression or unacceptable toxicity. All patients will be followed/contacted after discontinuation of protocol every 3 months.
Intervention type
Drug
Phase
Phase II
Drug names
Sorafenib (NEXAVAR®)
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
1. Overall Relapse Rate (ORR)
2. Overall Survival (OS)
3. Toxicity
4. Evaluation of panel of biomarkers, will be assessed every 4 weeks
5. Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30] version 3.0 pol and testicular cancer module), will be assessed every 12 weeks
Overall trial start date
01/03/2008
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male patients greater than 18 years of age
2. Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
3. Patients must have the disease not amendable to cure with either surgery or chemotherapy
4. Patients must have failed at least two cisplatin-based combination chemotherapy regimens
5. Failure on prior regimens will be defined as either:
5.1. A greater than or equal to 25% increase in sum of target lesions, new lesions, or
5.2. An increasing Alpha Fetoprotein (AFP) or Human Chorionic Gonadotropin (HCG) above the nadir level
6. Patients with at least one measurable lesion by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria
7. Adequate bone marrow, liver and renal function, assessed no longer than 14 days before treatment start, defined by the following laboratory test limits:
7.1. White Blood Cells (WBC) greater than 2.0 x 10^9/l and platelets greater than 60 x 10^9/l
7.2. Total bilirubin less than 2 x Upper Limit of Normal (ULN)
7.3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 5 x ULN
7.4. Serum creatinine less than 2 x ULN
8. World Health Organization (WHO) performance status 0, 1, 2
9. No concurrent chemotherapy or radiotherapy
10. Life expectancy of at least 12 weeks
11. Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
12. A signed informed consent must be obtained prior to any study specific procedures
13. All patients must agree to use adequate contraception during the whole study period
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
20
Participant exclusion criteria
1. Patients not fulfilling of inclusion criteria
2. Primary radiotherapy in the field of target lesion
3. Major surgery (Retroperitoneal Lymph Node Dissection [RPLND]) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.
4. Known serious and active bacterial, viral or fungal infection (greater than grade II Common Terminology Criteria for Adverse Events [CTC-AE]) including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) carrier state
5. Previous or concurrent malignancy except for basal cell carcinoma of the skin
6. Uncontrolled hypertension
7. Thrombotic or embolic event in last 6 months prior to inclusion
8. Impairment of Gastrointestinal (GI) tract, or GI disease that may influence the bioavailability of oral sorafenib
9. Substance and alcohol abuse (nicotine use is allowed)
10. Known or suspected hypersensitivity to sorafenib
11. Participance in any other clinical trial using investigational drug within 4 weeks prior to study entry
12. Prior use of investigational or licensed angiogenesis and Raf kinase or Mitogen-activated Extracellular-signal-Regulated Kinase (ERK) (MEK) inhibitors
13. Patient unwilling or unable to give informed consent
14. Any condition that may in the investigators opinion jeopardize the safety of the patient or his compliance in the study
Recruitment start date
01/03/2008
Recruitment end date
01/09/2010
Locations
Countries of recruitment
Poland
Trial participating centre
Roentgena 5
Warsaw
02781
Poland
Sponsor information
Organisation
Prof. Grzegorz Madej Memorial Foundation "Win the health" (Fundacja "Wygrajmy Zdrowie" im Prof. Grzegorza Madeja) (Poland)
Sponsor details
P.O. Box 20
Warsaw 10
00956
Poland
+48 (0)510 723 802
i.skoneczna@wygrajmyzdrowie.pl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Bayer Pharmaceuticals Poland Sp. z.o.o. (Poland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary