Germ cell tumor, metastatic, relapsed or refractory MedDRA version: 17.0 Level: PT Classification code 10055103 Term: Testicular cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Afinitor
Pharmaceutical Form: Tablet
INN or Proposed INN: EVEROLIMUS
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
Male
Inclusion criteria
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 =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: =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Percentage of patients progression-free at 12 weeks ;Secondary Objective: Objective response rate Disease control rate Progression-free survival Overall survival Safety profile ;Primary end point(s): Percentage of patients progression-free ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;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) | — |
Countries
Germany
Contacts
Public ContactDr. med. Martin Fenner
Medizinische Hochschule Hannover
Outcome results
None listed