E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Germ cell tumor, metastatic, relapsed or refractory |
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E.1.1.1 | Medical condition in easily understood language |
Germ cell tumor, metastatic, reappearing or resistant to treatment |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10055103 |
E.1.2 | Term | Testicular cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Percentage of patients progression-free at 12 weeks |
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E.2.2 | Secondary objectives of the trial |
Objective response rate Disease control rate Progression-free survival Overall survival Safety profile
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male patients >= 18 years old • Patients with histologically proven seminomatous or non-seminomatous germ cell cancer • Disease progression during cisplatin-based chemotherapy or Disease progression or relapse after high-dose chemotherapy or Disease progression or relapse after at least 2 different cisplatin-based regimens and contraindications for high-dose chemotherapy • Patients must have received prior combination chemotherapy with gemcitabine,oxaliplatin and paclitaxel (GOP). Prior treatment with a combination oftwo ofthese drugs is allowed in case of contraindications for GOP. • Disease progression at study entry: progressive disease according to RECIST criteria in baseline exarninations or tumor marker increase > 25% within 4 weeks before study entry. • ECOG performance status <= 2 • Life expectancy >=3 months • Adequate bone marrow function: absolute neutrophil count > 1.5 x 10E9/l, platelets > 75 x 10E9/l, hemoglobin > 9 g/dl. • Adequate liver function: serum bilirubin: <= 1.5x ULN, ALT and AST <= 2.5x ULN. For patients with known liver metastases: AST and ALT <= 5x ULN. • Adequate renal function: serum creatinine <= 2.0x UL . • Patients must either be surgically sterile or must agree to use effective contraception in the form of either hormonal contraception (implantable, patch) or double-barrier method (any double combination of intrauterine device, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) during study treatment • Signed written informed consent |
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E.4 | Principal exclusion criteria |
• Systemic anti tumor treatment within 21 days before study entry • Simultaneous radiotherapy ofthe only target lesion(s) • Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus,everolimus) • Patients receiving chronic systemic treatment with corticosteroids (dose of > 20 mg/day methylprednisone equivalent) or another immunosuppressive agent • Patients with unstable angina pectoris, myocardial infarction :s 6 months prior to first study treatment, congestive heart failure NYHA IH-IV or serious uncontrolled cardiac arrhythmias • Patients with severely impaired lung function: spirometry or DLCO < 50% ofthe normal predicted value • Uncontrolled diabetes: fasting serum glucose> 2.0x ULN. • Patients with an active or uncontrolled infection, including chronic Hepatitis B or C. • Patients who have a history of another primary malignancy and are off treatment for <= 3 years, with the exception of non-melanoma skin cancer • Patients who have undergone major surgery within 4 weeks prior to starting study drug (e.g. intra-thoracic, intra-abdominal, or intra-pelvic) or significant traurnatic injury, or who have not recovered from the side effects of any of the above • Patients who have participated in another clinical trial within 30 days before study entry • Other serious medical conditions that could impair the ability of the patient to participate in the study • Patients unwilling or unable to comply with the protocol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients progression-free |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. objective response rate (by RECIST and tumor markers) 2. disease control rate 3. progression-free survival 4. overall survival 5. safety profile. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. After Cycle 2, subsequent cycles, end of treatment and end of study (tumor markers); every 6 weeks until disease progression (CT/MRI of chest/abdomen) and every 12 weeks until disease progression (CT/MRI of brain/bone in case of known brain and bone metastasis) 2.-4. Regulalarly during study duration 5. After Cycle 1 and 2, subsequent cycles, end of treatment and end of study (AEs) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |