E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with previously treated metastatic soft tissue sarcoma |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
|
E.2.2 | Secondary objectives of the trial |
Determination of the rate of patients who are progression free at 3 and 6 months, changes in median period of survival and progression free survival, determination of toxicity |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histologically confirmed metastasized or locally inoperable soft tissue sarcoma - Progression or relapse after previous cytostatic treatment with adriamycin and/or an ifosfamide containing chemotherapeutic substance - Two-dimensionally measurable/evaluable tumor parameters - Previous radiotherapy is acceptable as long as the irradiated area does not include the only measurable lesion - Patient compliance and geographic proximity, which ensure the possibility of adequate Follow-up - Life expectancy of more than 3 months - ECOG <= 2 - Age at least 18 years - Adequate bone marrow function at the initiation of therapy - Adequate kidney function - Patient consent |
|
E.4 | Principal exclusion criteria |
- Previous or concurrent irradiation of the indicator lesion - Other concomitant tumor therapy - Severe impairment in hepatic function - Active Infection - Previous treatment with Pemetrexed - Second tumor within the past 5 years - Severely symptomatic cardiovascular and cerebrovascular disease - HIV, active Hepatitis B or C - Dementia, Cerebral stroke with cognitive deficits - Kidney function <= 79 ml/min (calculated according to MDRD) and inability to interrupt treatment with NSAIDs 2 days prior to and following administration of Pemetrexed - Inability or unwillingness to take folic acid, vitamin B12 or dexamethasone - Pleural or pericardial exudate, ascites without a drain (3rd Space) - Time Interval from the last course of chemotherapy < 4 weeks - Symptomatic CNS-Metastases - Gravidity or Lactation - Women of reproductive age without reliable contraception (neg. pregnancy test) - Participation in another clinical trial at the same time |
|
E.5 End points |
E.5.1 | Primary end point(s) | |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.3 |
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 | 6 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |