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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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)


Inclusion 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 ³ 2, or/and unwillingness to receive conventional chemotherapy

5. Negative pregnancy test or evidence of post-menopausal status for female patients.

6. RASGRP1/APTX gene expression ratio calculated at the screening >10 (part B.2 only)

Exclusion Criteria:

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 ³ 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-Hemorrhagic

9. Patients with documented cases of human immunodeficiency virus (HIV)

10. Peripheral Neuropathy or Neuropathic Pain grade > or = 2

11. Has known or suspected hypersensitivity or intolerance to boron, mannitol, or
heparin, if an indwelling catheter is used

12. Uncontrolled or severe cardiovascular disease including myocardial infarction within
6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart
failure (Attachment 7,NYHA Classification of Cardiac Disease), uncontrolled angina,
clinically significant pericardial disease, or cardiac amyloidosis

13. RASGRP1/APTX gene expression ratio calculated at the screening <10 (part B.2 only)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PART A: Assess the safety and tolerability of combined use of Zarnestra plus multiple ascending doses of Velcade in patients with de novo AML unfit for conventional chemotherapy (age >18 years) or in first or subsequent relapse ( >60 years).(COMPLETED)

Outcome Time Frame:

August 2007

Safety Issue:

No

Principal Investigator

Giovanni Martinelli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto di Ematologia ed Oncologia Medica "L.eA.Seràgnoli" Policlinico S.Orsola-Malpighi di Bologna

Authority:

Italy: The Italian Medicines Agency

Study ID:

HEMOS AML 0106

NCT ID:

NCT00510939

Start Date:

March 2007

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute myeloid leukemia
  • NFkB activity and leukemia
  • expression of NFkB
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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