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Systemic MastocytosisPhase 2NCT00979160

Evaluation of Response of Dasatinib to Treat Mastocytosis

A Phase 2 study testing Dasatinib in people with Systemic Mastocytosis, run by Federico II University at 12 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 a multicenter, open-label, single arm phase II non-randomized study of dasatinib in which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of dasatinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Mastocytosis
What is being tested?
Dasatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
12 sitesItaly
Study dates
Nov 2009to Dec 2012
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

  • Signed Written Informed Consent
  • Subjects with confirmed diagnosis of SM according to the WHO criteria and the following must be met:
  • All SM clinical variations, smoldering SM should have ≥ 2 B-findings and severe mediator related symptoms.
  • KIT mutation status on BM cells must be available at baseline or ≤ 6 months prior to study entry.
  • Subjects may have not prior treatment with chemotherapeutic regimen including imatinib or have either failed a prior chemotherapeutic regimen including imatinib or other agent.
  • At least two weeks must have elapsed from the last dose of chemotherapy, hormonal therapy, immunotherapy, biological therapy or investigational product and radiation therapy, and subjects must have recovered to baseline or Grade ≤ 1 (NCI CTCAE, version 3.0) from the toxicities resulting from any of those recent therapies prior to the first dose of dasatinib.
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  • ECOG performance status of 0, 1 or 2.
  • Subject must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and requirements of the study.
  • Adequate liver and renal functions defined as:
  • Total bilirubin ≤ 2 x upper limit of normal (ULN) or ≤ 4 ULN if the sole cause of liver elevation is due to SM
  • AST, ALT and alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5 ULN if the sole cause of liver elevation or bone compromise is due to SM
  • Serum creatinine ≤ 2 x ULN
  • Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.
  • Men and women, ages 18 and older.
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.

Who cannot join

  • WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to at least 4 weeks after the last dose of investigational product.
  • Women who are pregnant or breastfeeding
  • Indolent SM (presence of B-findings without severe mediator-related symptoms)
  • Pericarditis, clinically significant pleural effusion or ascites within 12 months prior to study entry not attributable to SM.
  • Pulmonary infiltrates within 4 weeks prior to study entry or abnormal chest X-ray at baseline not attributable to SM.
  • Any surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) within 14 days prior to initiation of dasatinib therapy.
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  • Presence of active bacterial, fungal or viral infections at study entry.
  • Clinically significant cardiac disease (NYHA Class III or IV) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, or cardiomyopathy.
  • Abnormal QTcF interval prolonged ( ≥ 450 msec) after electrolytes have been corrected on baseline ECG.
  • Malabsorption syndrome not attributable to SM or uncontrolled (e.g. not corrected by antimediator therapy) gastrointestinal toxicities (nausea, diarrhea, vomiting) NCI CTCAE Grade = 2.
  • Clinically-significant coagulation or platelet function disorder (eg, known von Willebrand's disease).
  • Prior or concurrent malignancy, except for the following:
  • Adequately treated basal cell or squamous cell skin cancer.
  • Cervical carcinoma in situ.
  • Adequately treated Stage I or II cancer from which the subject is currently in complete remission.
  • Or any other cancer from which the subject has been disease-free for 3 years.
  • Cytopenia(s): ANC <1000/L, or hemoglobin <10 g/dL, or platelets < 100.000/L at study entry unless the pretreatment bone marrow exam and/or presence of disease-related hypersplenism establish that the likely causes of the cytopenia(s) is related to SM.
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, serious uncontrolled medical disorder or active infection 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 subject inappropriate for this study.
  • Intolerance to dasatinib.
  • Administration of hematopoietic growth factors within 14 days prior to study entry.
  • Medications that are generally considered to have a risk of causing "Torsades de Pointes"
  • Current therapy with steroids must be tapered off within 14 days prior to the start of study medication if it is anticipated that subjects can be tapered off these drugs. Otherwise, for steroid-requiring subjects, investigators should attempt to taper to the minimal dose possible at the time of initiation of dasatinib therapy.
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Trial locations and contacts

12 sites in 1 country.

Massimo Triggiani, prof. contact

+390817462218

triggian@unina.it

12 sites in 1 country

Italy12 sites

  • Istituto di ematologia "L e A Seragnoli" - Policlinico universitario Sant'Orsola-Malpighi

    Bologna, 40138

    Giovanni Martinelli, MD, +39516363680, giovanni.martinelli2@unibo.it

    Barbara Lama, MD, +390516363827, barbara.lama@unibo.it

  • Dipartimento di Ematologia - S.O.D. di Ematologia Università degli Studi di Firenze - Azienda Ospedaliera Careggi

    Florence, 50134

    Alessandro Vannucchi, MD, +39 0557947688, a.vannucchi@unifi.it

    Lisa Pieri, MD

  • Divisione di Ematologia Ospedale Niguarda Ca' Grande

    Milan, 20162

    Roberto Cairoli, MD, +39 02 64442668, roberto.cairoli@ospedaleniguarda.it

  • Divisione di Allergologia e Immunologia Clinica, Università Federico II

    Naples, 80131

    Massimo Triggiani, MD, +390817462218, triggian@unina.it

    Diomira Magliacane, MD

  • Divisione di Ematologia Università di Torino Ospedale San Luigi Gonzaga

    Orbassano (TO), 10043

    Daniela Cilloni, MD, +39 011 9026610, daniela.cilloni@unito.it

    Emanuela Messa, MD

  • Istituto di Ematologia Università degli Studi di Pavia - Policlinico S. Matteo IRCCS

    Pavia, 27100

    Serena Merante, MD, +39 0382 503082, s.merante@smatteo.pv.it

  • Unità di Ematologia e Trapianto Osseo CROB, Centro di Riferimento Oncologico di Basilicata +39 0972 726729 Fax +30 0972 726217 e-mail: p.musto@crob.it

    Rionero in Vulture (Pz)

    Pellegrino Musto, MD, +39 0972 726729, p.musto@crob.it

  • Ematologia Tor Vergata University Hospital

    Roma, 00133

    Adriano Venditti, MD, +39 06 20903219, adriano.venditti@uniroma2.it

    Sergio Amadori, MD

  • Divisione di Ematologia Policlinico Universitario "Agostino Gemelli"

    Roma, 00168

  • Ematologia e Trapianti Università degli Studi di Siena - Policlinico S. Maria alle Scotte

    Siena, 53100

    Michela Rondoni, MD, +39 0577 586798, michela.rondoni3@unibo.it

    Francesco Lauria, MD

  • Divisione di Ematologia e Trapianto Midollo Osseo Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

    Udine, 33100

    Mario Tiribelli, MD, +39 0432 55966, mario.tiribelli@uniud.it

    Renato Fanin, MD

  • Sezione di Ematologia - Dipartimento di Medicina Clinica e Sperimentale Policlinico G.B.Rossi - Università degli Studi di Verona

    Verona, 37134

    Roberta Zanotti, MD, +39 045 8074812, roberta.zanotti@univr.it

Other trials in Italy

About this study

Official title: Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis

This is a multicenter, open-label, single arm phase II non-randomized study of dasatinib in which subjects with systemic mastocytosis (SM) will be treated with a continuous regimen of dasatinib.

Upon completion of a treatment induction period, subjects will be treated with dasatinib at a dose of 100 mg per os (OS) once daily (QD).

Read the detailed description

Dasatinib may have clinical efficacy and is safe in subjects with SM. This Multicenter, open-label, single arm Phase II study will investigate the clinical response rate in terms of both B/C findings and mediator-related symptoms.

30 adult patients will be treated with a continuous regimen of dasatinib at a starting dose of 20 mg administered orally (PO) once daily (QD), that can be escalated up to 100 mg QD at the end of Week 3. Upon completion of a treatment induction period, subjects will be treated with dasatinib at a daily dose of 100 mg PO QD. Patients will remain on dasatinib treatment for 12 months unless disease progression, unacceptable toxicity or other reasons determine treatment discontinuation. Subjects may continue receiving protocol therapy as long as they are deriving a clinical benefit.

Additionally, all subjects will be followed until disease progression, death, or 12 months beyond discontinuation from study treatment.

The total duration of the study is estimated to 36 months.

Being tested
Dasatinib
Medical subject headings
Mastocytosis, Systemic

What participants receive

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

  • DasatinibDrug

    Also called BMS-354825-03

    Starting dosage 20mg once daily, that can be escalated up to 100mg once daily. Patient will remain on treatment for 12 months.

Study groups in NCT00979160
Study groupRoleWhat they receive
DasatinibExperimentalPatient will be treat at a starting dose of 20mg once daily, that can be escalated up to 100mg once daily.
Receives: Drug: Dasatinib

What is being measured

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

  1. To assess the clinical response rate in terms of both B/C findings and mediator-related symptoms in subjects with SM who have been treated with dasatinib.

    Measured: December 2011

Secondary outcomes (3)

  1. To assess of the Time to Response (TTR), Duration of Response (DOR) and Progression-Free survival (PFS).

    Measured: December 2012

  2. To evaluate the changes in specific biological markers and molecular mutations.

    Measured: June 2012

  3. To evaluate the safety and toxicity of dasatinib in this population.

    Measured: December 2011

Timeline

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

  1. First posted17 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2011 (estimated)
  4. Study completionDec 2012 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979160
Sponsor's protocol ID
CA 180-287
Status last verified
Sep 2009
First submitted
16 Sep 2009
Last updated
18 Sep 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Systemic Mastocytosis, run by Federico II University at 12 sites 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 15 inclusion and 24 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 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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 Massimo Triggiani, prof. (+390817462218, triggian@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the clinical response rate in terms of both B/C findings and mediator-related symptoms in subjects with SM who have been treated with dasatinib. (time frame: December 2011). 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 NCT00979160.

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 18 Sep 2009.

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