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Acute Myeloid LeukemiaPhase 2HEMOS AML 0106NCT00510939

Study to Assess the Safety, Tolerability, and Efficacy of Tipifarnib Plus Bortezomib in the Treatment of Acute Myeloid Leukemia

A Phase 2 study testing Tipifarnib plus Bortezomib in people with Acute Myeloid Leukemia, run by University of Bologna at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is one of the first studies of combination of Zarnestra plus Velcade in man. A primary objective of the study is therefore to assess the safety and tolerability of multiple doses of Zarnestra plus Velcade in patients with AML. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Tipifarnib plus Bortezomib
How many people
72 participants
Where
1 siteItaly
Study dates
Mar 2007to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of written informed consent
  • Male or female aged >18 years with newly diagnosed Acute Myeloid Leukemia (AML), de novo or secondary, unfit for conventional chemotherapy
  • Male or female with Acute Myeloid Leukemia in first relapse ( > 60 years)
  • WHO performance status ³ 2, or/and unwillingness to receive conventional chemotherapy
  • Negative pregnancy test or evidence of post-menopausal status for female patients.
  • RASGRP1/APTX gene expression ratio calculated at the screening >10 (part B.2 only)

Who cannot join

  • Serum bilirubin 2 x> Upper Limit of Normal (ULN)
  • Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) >3.5 x ULN
  • Serum creatinine ³ 2.5 x ULN or 24-hour creatinine clearance £ 60 mL/min (measured or calculated by Cockcroft-Gault)
  • Patients with AML of FAB M3 classification (APL)
  • 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
  • Any clinically defined central nervous system AML.
Show all 13Show fewer
  • Participation in an investigational drug study within the 30 days prior to entry
  • Evidence of uncontrolled infection or CNS-Hemorrhagic
  • Patients with documented cases of human immunodeficiency virus (HIV)
  • Peripheral Neuropathy or Neuropathic Pain grade > or = 2
  • Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
  • 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
  • RASGRP1/APTX gene expression ratio calculated at the screening <10 (part B.2 only)

Trial locations and contacts

1 site in 1 country.

Giovanni Martinelli, MD contact

+39 051 6363829

gmartino@alma.unibo.it

Barbara Lama, MD contact

+39 051 6363827

barbara.lama@unibo.it

Italy1 site, 1 recruiting

  • Istituto di Ematologia "L e A Seragnoli" Policlinico S.Orsola-Malpighi

    Bologna, 40138

    Giovanni Martinelli, MD, +039 051 6363829, martg@tin.it

    Recruiting

Other trials in Italy

About this study

Official title: 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)

This is one of the first studies of combination of Zarnestra plus Velcade in man. A primary objective of the study is therefore to assess the safety and tolerability of multiple doses of Zarnestra plus Velcade in patients with AML.

New treatments for patients that are untreatable with intensive chemotherapy aged de novo AML patients or post-relapse AML are urgently required since, at present, many of the drugs used for second line therapy are the same as those used for first induction and response rates are much lower.

Read more
  • The following evidence suggests that Velcade plus Zarnestra can be an attractive therapeutic combination for: AML patients.
  • Affymetrix gene profiling data showed expression of NFkB1 in all of 5 myeloid cell lines cell lines tested and 35% of over 250 patient samples ( data generated in collaboration with Sergio Ferrari and Pier Paolo Piccaluga unpublished results, our Institute and University of Modena,Italy)
  • Preclinical evidence showed that AML cells in suspension culture were prevented to develop de novo drug resistance and mediated drug resistance.

In Part B additional patients with AML will be treated to further characterize the tolerability,biological effects, and clinical efficacy of the combination Velcade plus Zarnestra. Patients on treatment for AML will undergo regular bone marrow aspirates and biopsies to assess responses to treatment. This will facilitate frequent assessment of biological endpoints (reduction in expression and phosphorylation of IKKb kinase, and downstream markers of signalling along with apoptosis, survival, proliferation and cellular size and ploidy) will be made in an attempt to confirm that the desired biological activity has been achieved at the maximum tolerated dose.

Being tested
Tipifarnib plus Bortezomib
Keywords
Acute myeloid leukemia, NFkB activity and leukemia, expression of NFkB
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tipifarnib plus BortezomibDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: August 2007

  2. Part B.1: Assess the effect of Tipifarnib plus the defined in part A dose of Velcade in patients with de novo AML unfit for conventional chemotherapy (age >18 years) or in Patients in first or subsequent relapse ( >60 years) (COMPLETED)

    Measured: December 2008

  3. Part B.2: Evaluate the overall response (CR, PR, HI) of patients with a RASGRP1/APTX gene expression ratio > 10, identified as predictive of a good clinical response to tipifarnib in patients with de novo AML unfit for conventional chemotherapy.

    Measured: June 2010

Secondary outcomes (3)

  1. To investigate the effect of Velcade on the expression of NFkB, and biomarkers of NFkB

  2. Including phosphorylation of c-Rel on leukaemic blasts by flow cytometry, protein analysis,

  3. Immunohistochemistry, and/or mRNA profiling using gene and SNPs DNA chip.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2007 (estimated)
  2. Study startMar 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00510939
Sponsor's protocol ID
HEMOS AML 0106
Other IDs
EudraCT 2007-000273-35
Acronym
HEMOS AML 0106
Status last verified
Aug 2009
First submitted
2 Aug 2007
Last updated
14 Aug 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tipifarnib plus Bortezomib in people with Acute Myeloid Leukemia, run by University of Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Giovanni Martinelli, MD (+39 051 6363829, gmartino@alma.unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary 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) (time frame: August 2007). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00510939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2009.

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