Phase II study of PHA-848125AC as second line-treatment in pemetrexed pre-treated malignant pleural mesothelioma patients - ND

• Conditions: Malignant Pleural Mesothelioma; MedDRA version: 9.1Level: LLTClassification code 10059518Term: Pleural mesothelioma malignant

• Registration Number: EUCTR2008-005831-13-IT
• Lead Sponsor: ERVIANO MEDICAL SCIENCES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Signed and dated IRB/IEC-approved Informed Consent 2. Histologically or cytologically proven diagnosis of Malignant Pleural Mesothelioma (MPM), inoperable, in relapse after failure of prior pemetrexed-containing treatment (only one prior chemotherapy regimen allowed) 3. Presence of unidimensionally and/or bidimensionally measurable disease. Patients undergoing palliative radiation therapy for painful lesions are allowed to enter the study, provided that they have measurable disease outside the irradiated site. 4. No or asymptomatic pleural effusion. Patients with symptomatic pleural effusions can be enrolled provided that they have their effusions drained prior to enrollment on the clinical trial. 5. Age >/= 18 years 6. ECOG performance status 0-1 7. Estimated life expectancy of at least 3 months 8. Negative pregnancy test (if female in reproductive years) 9. Agreement upon the use of effective contraceptive methods (hormonal or barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation, if men and women of child producing potential 10. Adequate liver function: - Bilirubin /= 3.0 g/dL - AST (SGOT), ALT (SGPT) /= 1,500 cells/mm3 - Platelet count >/= 100,000 cells/mm3 - Hemoglobin >/= 9.0 g/dL 13. At the time of start of treatment, at least 4 weeks must have elapsed since completion of prior chemotherapy, surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated) 14. With the exception of alopecia, resolution of all acute toxic effects of any prior chemotherapy, surgery or radiotherapy to NCI CTC (Version 3.0) grade 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

Exclusion Criteria

1. 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 2. Grade >1 retinopathy 3. Known brain metastases 4. Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment 5. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy 6. Known infection with HIV, active hepatitis B or hepatitis C 7. Pregnant or breast feeding women 8. Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri 9. Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceeding treatment start 10. Diabetes mellitus uncontrolled 11. Gastrointestinal disease (e.g. Crohn?s disease, ulcerative colitis, or short gut syndrome) that would impact on drug absorption 12. Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline 13. Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson?s disease and extra-pyramidal syndromes 14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the antitumor activity in terms of TTP of PHA-848125AC as second-line treatment in pemetrexed-pretreated patients with MPM.;Secondary Objective: - to assess additional measures of tumor control to further characterize the efficacy profile of PHA-848125AC in MPM patients - to evaluate the safety profile of repeated administrations of PHA-848125AC in MPM patients - to monitor blood levels of PHA-848125AC through a limited PK sampling procedure.;Primary end point(s): The primary endpoint will be based on the Time to Tumor Progression (TTP), i.e. the time from the date of treatment start to the date of first documentation of objective tumor progression, objective tumor recurrence or of death due to progressive disease (PD), whichever comes first. The primary efficacy analysis will be performed on the proportion of evaluable patients in a progression free-status at 12 weeks: 12-week PD-free rate.