Testicular CancerPhase 2GCTNCT00772694
Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
A Phase 2 study testing sorafenib in people with Testicular Cancer, run by Fondation Wygrajmy Zdrowie at 1 site in Poland.
Trial summary
Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur most frequently in testis. The incidence is about 1%, but is increasing in the majority of developed countries. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2008to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients > 18 years of age
- Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
- Patients must have the disease not amendable to cure with either surgery or chemotherapy
- Patients must have failed at least two cisplatin-based combination chemotherapy regimens.
- Failure on prior regimens will be defined as either:
- A ≥ 25% increase in sum of target lesions, new lesions, or
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- An increasing AFP or HCG above the nadir level.
- Patients with at least one measurable lesion by CT scan or MRI according to RECIST criteria
- Adequate bone marrow, liver and renal function, assessed no longer than 14 days before treatment start, defined by the following laboratory test limits: WBC > 2.0 x 109/l and platelets > 60 x 109/l, total bilirubin < 2 x upper limit, AST and ALT < 5 x upper limit normal, serum creatinine < 2 x UNL
- WHO Performance Status 0, 1, 2
- No concurrent chemotherapy or radiotherapy
- Life expectancy of at least 12 weeks
- Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- A signed informed consent must be obtained prior to any study specific procedures
- All patients must agree to use adequate contraception during the whole study period
Who cannot join
- Patients not fulfilling of inclusion criteria
- Primary radiotherapy in the field of target lesion
- Major surgery (RPLND) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.
- Known serious and active bacterial, viral or fungal infection (> grade II CTC-AE) including HBV, HCV and HIV carrier state.
- Previous or concurrent malignancy except for basal cell carcinoma of the skin
- Uncontrolled hypertension.
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- Thrombotic or embolic event in last 6 months prior to inclusion.
- Impairment of gastrointestinal tract, or GI disease that may influence the bioavailability of oral sorafenib
- Substance and alcohol abuse (nicotine use is allowed)
- Known or suspected hypersensitivity to sorafenib.
- Participants in any other clinical trial using investigational drug within 4 weeks prior to study entry
- Prior use of investigational or licensed angiogenesis and RAF kinase or MEK inhibitors.
- Patient unwilling or unable to give informed consent
- Any condition that may in the investigator's opinion jeopardize the safety of the patient or his compliance in the study.
Trial locations and contacts
1 site in 1 country.
Agnieszka Chaladaj-Kujawska, MD contact
Poland1 site, 1 recruiting
- Recruiting
Chemotherapy Unit, Dept of Urology, Instituite of Oncology
Warsaw, 02781
Iwona A Skoneczna, MD
Agnieszka Chaladaj-Kujawska, MD
About this study
Official title: Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur most frequently in testis. The incidence is about 1%, but is increasing in the majority of developed countries. The testicular cancer is an extremely important oncological condition due to his high rate of 80-90% of curability, which can be achieved by combination of chemotherapy and surgery.
Some of 20-30% of patients will experience disease progression after first line cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage chemotherapy will result in long term remissions in < 50% of patients (VeIP - vinblastine, ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel, ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine), 20% CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be cured, usually with subsequent consolidation surgery. At that stage the disease is usually chemorefractory and there are no other chemotherapy regimens of proven benefit (7).
The purpose of this study is to determine if multiple-relapsed chemorefractory pts may benefit from sorafenib monotherapy.
- Conditions
- Testicular Cancer
- Being tested
- sorafenib
- Keywords
- testicular cancer, germ cell cancer, sorafenib
- Medical subject headings
- Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sorafenibDrug
Also called Nexavar
tablets 200mg, 400mg bid continuously in 4-week cycles
| Study group | Role | What they receive |
|---|---|---|
| sorafenib | Experimental | drug Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: one year
Secondary outcomes (1)
ORR Evaluation of the usefulness the CT with vasculature visualisation option in the measurement of the objective response Evaluation of quality of life
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Wygrajmy Zdrowie
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772694
- Sponsor's protocol ID
- 12602
- Other IDs
- PL/ 183/UR/CEBK/04/08, EudraCT 2007-007599-40
- Acronym
- GCT
- Status last verified
- Oct 2008
- First submitted
- 14 Oct 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib (NEXAVAR) Monotherapy in Patients With Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy
- ClinicalTrials.gov ID
- NCT00772694
- Acronym / sponsor ID
- GCT / 12602
- Conditions
- Testicular Cancer
- Keywords
- testicular cancer, germ cell cancer, sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fondation Wygrajmy ZdrowieUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Germ cell tumors, a relatively rare disease, but most common malignancy in young males, occur most frequently in testis. The incidence is about 1%, but is increasing in the majority of developed countries. The testicular cancer is an extremely important oncological condition due to his high rate of 80-90% of curability, which can be achieved by combination of chemotherapy and surgery.
Some of 20-30% of patients will experience disease progression after first line cisplatin-based chemotherapy and salvage 2nd line conventional-dose cisplatin-based salvage chemotherapy will result in long term remissions in < 50% of patients (VeIP - vinblastine, ifosfamide, cisplatin, VIP/PEI - ifosfamide, etoposide, cisplatin, TIP - paclitaxel, ifosfamide, cisplatin). In multiple relapsed patients the 3rd line chemotherapy can induce remission in up to 40% (gemcitabine, oxaliplatin), 23% RR (TG - paclitaxel, gemcitabine), 20% CR (IPO - irinotecan, paclitaxel, oxaliplatin), but only small proportion of them can be cured, usually with subsequent consolidation surgery. At that stage the disease is usually chemorefractory and there are no other chemotherapy regimens of proven benefit (7).
The purpose of this study is to determine if multiple-relapsed chemorefractory pts may benefit from sorafenib monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sorafenib | Experimental | Drug: sorafenibdrug |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male patients > 18 years of age
- Patients with histologically proven germ cell neoplasm (gonadal or extragonadal primary)
- Patients must have the disease not amendable to cure with either surgery or chemotherapy
- Patients must have failed at least two cisplatin-based combination chemotherapy regimens.
- Failure on prior regimens will be defined as either:
Key exclusion criteria (14 listed)
- Patients not fulfilling of inclusion criteria
- Primary radiotherapy in the field of target lesion
- Major surgery (RPLND) within 4 weeks before the start of study drug or concurrent serious non-healing wounds, ulcers or bone fractures.
- Known serious and active bacterial, viral or fungal infection (> grade II CTC-AE) including HBV, HCV and HIV carrier state.
- Previous or concurrent malignancy except for basal cell carcinoma of the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sorafenibAlso: Nexavartablets 200mg, 400mg bid continuously in 4-week cycles | Drug | sorafenib |
Primary outcome
Progression free survival
Time frame: one year
1 secondary outcome
ORR Evaluation of the usefulness the CT with vasculature visualisation option in the measurement of the objective response Evaluation of quality of life
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Chaladaj-Kujawska, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sorafenib in people with Testicular Cancer, run by Fondation Wygrajmy Zdrowie at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iwona A Skoneczna, MD (+48225462098, i.skoneczna@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2008.