A Phase II, Open-Label, Multi-centre, 2-part study to assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Newly Diagnosed Acute Myeloid Leukemia AML unfit for conventional chemotherapy 18 years or in Patients with Acute Myeloid Leukemia in first relapse 60 years - AML 0106 Hemos

• Conditions: Acute Myeloid Leukemia; MedDRA version: 6.1Level: HLTClassification code 10024291

• Registration Number: EUCTR2007-000273-35-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-04
• Last Update Posted: 24 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

For inclusion in the study subjects must fulfill all of the following criteria 1. Provision of written informed consent 2. Male or female aged 18 years with newly diagnosed Acute Myeloid Leukemia AML , de novo or secondary, unfit for conventional chemotherapy 3. Male or female with Acute Myeloid Leukemia in first relapse 60 years 4. WHO performance status 2, or/and unwillingness to receive conventional chemotherapy 5. Negative pregnancy test or evidence of post-menopausal status for female patients. For inclusion in this genetic research, subjects must fulfill the following criterion 1. Provision of informed consent for genetic research. 2. If a subject declines to participate in the genetic research, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
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

Exclusion criteria Any of the following is regarded as a criterion for exclusion from the study 1. Serum bilirubin 2 x Upper Limit of Normal ULN 2. Aspartate aminotransferase AST/SGOT or alanine aminotransferase ALT/SGPT 3.5 x ULN 3. Serum creatinine 2.5 x ULN or 24-hour creatinine clearance 60 mL/min measured or calculated by Cockcroft-Gault 4. Patients with AML of FAB M3 classification APL 5. Patients with a history of another primary malignancy within the previous 1 year other than basal cell carcinoma or carcinoma in situ, the patient is in remission 6. Any clinically defined central nervous system AML. 7. Participation in an investigational drug study within the 30 days prior to entry 8. Evidence of uncontrolled infection or CNS-Hemorragic 9. Patients with documented cases of human immunodeficiency virus HIV 10. Peripheral Neuropathy or Neuropathic Pain grade 2

Study & Design

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