Condition category
Cancer
Date applied
06/12/2007
Date assigned
07/01/2008
Last edited
07/01/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 investigator’s 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

http://www.wygrajmyzdrowie.pl

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

Publication citations

Additional files

Editorial Notes