E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of patients with breast, ovarian, pancreatic, colorectal, small and non-small cell lung cancers. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
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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 |
To determine if PHA-739358 has an antitumor activity against breast, ovarian, pancreatic, colorectal, small and non-small cell lung cancers. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the antitumor activity of PHA-739358 in comparison to the last prior therapy To evaluate the safety profile of PHA-739358. To monitor the PK of PHA-739358 in plasma To analyze the gene expression profile in tumor biopsies before and after treatment with PHA-739358 and to investigate any possible correlation with clinical/radiological assessment in consenting patients suffering from metastatic breast cancer . |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Patients with histologically or cytologically documented progressive advanced/metastatic disease in one of the following solid tumors see below Breast cancer in 3rd line of chemotherapy , Ovarian cancer 3rd line, platinum resistant/refractory disease , Colorectal cancer 3rd line , Pancreatic Cancer 2nd line , Small Cell Lung Cancer 2nd line , Non Small Cell Lung Cancer 2nd line . 2.Prior chemotherapy must have been completed 2 weeks before study entry. 3.Available information on the first day of administration of the previous chemotherapy and the precise date when progression has been assessed. 4.Prior radiotherapy is allowed provided that a minimum of 2 weeks has elapsed between the end of prior radiotherapy and the entry into the trial. 5.Age 18 years or older 6.ECOG performance status 0 1 7.Life expectancy of at least 3 months 8.Hematological and biochemical parameters Bilirubin / 1,5 UNL AST/ALT / 2,5 UNL / 5 UNL in case of liver metastases ALP / 2,5 UNL / 5 UNL in case of liver and/or bone metastases Creatinine within normal limits if out of range then perform the Creatinine clearance evaluation / 50 ml/min ANC / 1,500 cells/mm3 Platelets count / 75,000 cells/mm3 Hemoglobin / 10 g/dl 9.All acute toxic effects excluding alopecia of any prior therapy must have resolved to NCI CTCAE version 3.0 grade / 1 10.Personally signed and dated IEC/IRB-approved informed consent form 11.Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. |
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E.4 | Principal exclusion criteria |
1.Previous high-dose chemotherapy requiring bone marrow rescue. 2.Concurrent enrollment in another investigational drug trial within the last 4 weeks 3.Known brain or leptomeningeal disease baseline computerized tomography CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system metastases 4.Uncontrolled hypertension with blood pressure exceeding 160/100 mmHg 5.Pregnancy or breast-feeding. Female patients must agree to avoid becoming pregnant during the study and in the following 3 months after the end of the treatment, be surgically sterile or be postmenopausal. Male patients must agree to have no intention to father a child during the study and in the following 3 months after the end of the treatment. 6.Abnormal LVEF 40 by Echocardiography or MUGA 45 7.Any of the following in the past 6 months myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or other significant thromboembolic event 8.Cardiac dysrhythmias grade / 2 according to NCI CTCAE version 3.0 9.Known active infection including known human immunodeficiency virus HIV positivity 10.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Rate at 4 months of treatment |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |