Phase II study of PHA-739358 administered by a 24-hour IV infusion every 14 days in advanced/metastatic breast, ovarian, colorectal, pancreatic, small cell lung and non small cell lung cancers. - ND
- Conditions
- Treatment of patients with breast, ovarian, pancreatic, colorectal, small and non-small cell lung cancers.MedDRA version: 6.1Level: SOCClassification code 10029104
- Registration Number
- EUCTR2006-003772-35-IT
- Lead Sponsor
- ERVIANO MEDICAL SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 232
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if PHA-739358 has an antitumor activity against breast, ovarian, pancreatic, colorectal, small and non-small cell lung cancers.;Secondary Objective: 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 .;Primary end point(s): Progression Free Rate at 4 months of treatment
- Secondary Outcome Measures
Name Time Method