Germ Cell TumorPhase 2NCT01466231
Everolimus in Refractory Testicular Germ Cell Cancer
A Phase 2 study testing Everolimus in people with Germ Cell Tumor, run by National Cancer Institute, Slovakia at 1 site in Slovakia.
Trial summary
Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Germ Cell Tumor
- What is being tested?
- Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSlovakia
- Study dates
- Nov 2011to Jun 2015
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Men aged 18 years or older
- ECOG performance status: 0-2,
- Histological confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
- Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
- Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy
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- Primary mediastinal GCTs in first relapse
- Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator,
- Measurable disease radiological
- Adequate hematologic function defined by WBC > 4000/mm3, platelet count > 100 000/mm3 and hemoglobin level > 9g/dl.
- Adequate liver function defined by a total bilirubin level < 1.5 ULN, and ALT, AST < 2,5 ULN and adequate renal function defined by serum creatinine ≤ 1.5 x ULN.
- At least 2 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry,
- At least 4 weeks must have elapsed since the last major surgery
- Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1,
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, -
Who cannot join
- Patients who do not fit inclusion criteria,
- Other prior malignancy except successfully treated non melanoma skin cancer
- Prior treatment with mTOR inhibitor
- No other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
- Female patients,
- Patients infected by the Human Immunodeficiency Virus (HIV),
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- Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study,
- Inability of oral intake, or drug absorption (e.g. malabsorption syndrome)
- Hypersensitivity to any compound of the drug,
- Sexually active men not using effective birth control if their partners are women of child-bearing potential.
- Patients with active CNS metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.
Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Read the detailed description
Treatment Schedule: Everolimus will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days.
Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
- Conditions
- Germ Cell Tumor
- Being tested
- Everolimus
- Keywords
- refractory germ cell cancer, everolimus
- Medical subject headings
- Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Afinitor
Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
| Study group | Role | What they receive |
|---|---|---|
| everolimus 10 mg po daily | Experimental | everolimus 10 mg po daily Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
according RECIST criteria version 1.1
Measured: 36 month
Secondary outcomes (7)
Favorable response rate
complete response with chemotherapy and/or surgery, partial response marker negative.
Measured: 36 month
Clinical benefit rate
(complete and partial response and stable disease > 6 months)
Measured: 36 month
Progression-free survival
expressed as median and as 12-weeks post-treatment initiation continuous progression-free survival rate
Measured: 36 month
Toxicity
Measured: 36 month
Frequency of grade III and IV adverse events
Measured: 36 month
Association between clinical outcome and biomarkers
Measured: 36 month
Serum tumor markers response
>90% decline of AFP and/or HCG
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germ Cell TumorStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Slovakia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jozef Mardiak, Prof, Principal investigator, National Cancer Institute (NCI)Michal Mego, Ass.prof., Study chair, National Cancer Institute, Slovakia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466231
- Sponsor's protocol ID
- GCTSK002
- Status last verified
- Jan 2016
- First submitted
- 31 Oct 2011
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.
- ClinicalTrials.gov ID
- NCT01466231
- Acronym / sponsor ID
- GCTSK002
- Conditions
- Germ Cell Tumor
- Keywords
- refractory germ cell cancer, everolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Institute, SlovakiaOther government
- Study start
- Nov 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Nov 2011 (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.
Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Detailed description
Treatment Schedule: Everolimus will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days.
Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| everolimus 10 mg po daily | Experimental | Drug: Everolimuseverolimus 10 mg po daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed written informed consent
- Men aged 18 years or older
- ECOG performance status: 0-2,
- Histological confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
- Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
Key exclusion criteria (11 listed)
- Patients who do not fit inclusion criteria,
- Other prior malignancy except successfully treated non melanoma skin cancer
- Prior treatment with mTOR inhibitor
- No other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
- Female patients,
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 |
|---|---|---|
| EverolimusAlso: AfinitorTablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. | Drug | everolimus 10 mg po daily |
Primary outcome
Response rate
Time frame: 36 month
according RECIST criteria version 1.1
7 secondary outcomes
Favorable response rate
Time frame: 36 month
Clinical benefit rate
Time frame: 36 month
Progression-free survival
Time frame: 36 month
Toxicity
Time frame: 36 month
Frequency of grade III and IV adverse events
Time frame: 36 month
Association between clinical outcome and biomarkers
Time frame: 36 month
Serum tumor markers response
Time frame: 36 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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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.
Jozef Mardiak, Prof principal investigator
National Cancer Institute (NCI)
Michal Mego, Ass.prof. study chair
National Cancer Institute, Slovakia
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 Everolimus in people with Germ Cell Tumor, run by National Cancer Institute, Slovakia at 1 site in Slovakia.
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 11 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: finished, as of the sponsor's last update on 12 Jan 2016. 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 Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 36 month). 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 12 Jan 2016.