E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
malignant pleural mesothelioma, non small cell lung cancer, pancreatic cancer and breast cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
Primary objective of the study is to verify the safety ( determined by clinical toxicities and measured by MTD and DLT) and feasibility of continuous (12 hours) intravenous infusion of Alimta. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are the study of pharmacokinetic parameters and to verify the efficacy of the drug given IV and CI in malignant pleural mesothelioma, non small cell lung cancer in second line, meatstatic pretreated breast cancer and pancratic cancer relapsed after conventional chemotherapy |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Patients must have histologically or cytologically confirmed of MPM, NSCLC, Metastatic Breast cancer, Pancreatic cancer in advanced stage, not surgically treatable and /or relapsed after conventional chemotherapy.
2.Patients may have preferably evaluable or measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease. Patients with evaluable disease may be enrolled in this dose-finding study provided that they are evaluable for toxicity.
3.Patients may be pretreated with chemo and/or previous radiotherapy. At least 1 month has to be passed from the end of previous treatment
4.Age >18 years.
5.Life expectancy of greater than 3 months .
6.ECOG performance status <2
7.Patients must have normal organ and marrow function as defined below:
-leukocytes >3,000/mL
-absolute neutrophil count >1,500/mL
-platelets >100,000/mL
-total bilirubin within normal institutional limits
-AST(SGOT)/ALT(SGPT)<2.5 X institutional upper limit of normal
-creatinine clearance >60 mL/min
8.The effects of Alimta on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Alimta is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
9.Ability to understand and the willingness to sign a written informed consent document.
10.Negative pregnancy test with 7 days from study entry. |
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E.4 | Principal exclusion criteria |
1.Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
2.Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Alimta or other agents used in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Maximum tolerated dose (MTD) and Dose limting toxicity (DLT) |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
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.8.3 |
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.8.5 | 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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |