| ISRCTN | ISRCTN56178790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56178790 |
| Secondary identifying numbers | 12602 |
- Submission date
- 06/12/2007
- Registration date
- 07/01/2008
- Last edited
- 07/01/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Iwona Skoneczna
Scientific
Scientific
Roentgena 5
Warsaw
02781
Poland
| Phone | +48 (0)22 5462098 |
|---|---|
| i.skoneczna@coi.waw.pl |
Study information
| Study design | Single arm, non-randomised, single institution, phase II trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Sorafenib (NEXAVAR®) monotherapy in patients with inoperable/recurrent germ cell carcinoma refractory to chemotherapy |
| Study acronym | MRS |
| Study objectives | Sorafenib prolongs Progression-Free Survival (PFS) in patients with inoperable/recurrent germ cell carcinoma refrectory to chemotherapy. |
| Ethics approval(s) | Submitted, not reviewed yet as of 06/12/2007. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Sorafenib (NEXAVAR®) |
| Primary outcome measure | 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 study start date | 01/03/2008 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2008 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- Poland
Study participating centre
Roentgena 5
Warsaw
02781
Poland
02781
Poland
Sponsor information
Prof. Grzegorz Madej Memorial Foundation "Win the health" (Fundacja "Wygrajmy Zdrowie" im Prof. Grzegorza Madeja) (Poland)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 20
Warsaw 10
00956
Poland
| Phone | +48 (0)510 723 802 |
|---|---|
| i.skoneczna@wygrajmyzdrowie.pl | |
| Website | http://www.wygrajmyzdrowie.pl |
Funders
Funder type
Industry
Bayer Pharmaceuticals Poland Sp. z.o.o. (Poland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
