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ChordomaPhase 2NCT00150072

Efficacy and Safety of Imatinib in Chordoma

A Phase 2 study testing imatinib in people with Chordoma, run by Novartis Pharmaceuticals at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in patients affected by chordoma, need to be confirmed by a Phase II study, whose primary endpoint will be the formal assessment of clinical and pathological response. Read more about this study

Who is it for?
Any age
Conditions the study is for
Chordoma
What is being tested?
imatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
12 sitesin 2 countries
Study dates
Oct 2004to Apr 2008
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histological diagnosis of chordoma.
  • Biomolecular or immunohistochemical evidence of Imatinib mesylate target (PDGFRβ activation and/or presence of PDGFB). Biomolecular assessment of PDGFRβ activation should be made whenever possible. To this end, if frozen material is not available, obtaining of, fresh material is encouraged, if it should be obtained with no major distress for the patient, preferably through an incisional biopsy (to allow immunoprecipitation) or, if this is not feasible, a Trucut biopsy (to allow Western Blot assessment). However, if frozen or fresh material cannot be obtained, paraffined material is also acceptable.
  • The biomolecular assessment will be centralized to the reference centers (to be defined).
  • Measurable or evaluable disease
  • Surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or easier, or likely more feasible, after cytoreduction, and/or metastatic disease. Debulking surgery before enrolment is allowed. In this case, enrolment should occur at least one month after surgery
  • Performance status 0, 1, 2 or 3 (ECOG) (see § 8.1).
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  • Adequate end organ function, defined as the following: total bilirubin <1.5 x ULN, SGOT and SGPT <2.5 x UNL (or <5 x ULN if hepatic metastases are present), creatinine <1.5 x ULN.
  • Adequate bone marrow function, defined as the following: ANC >1.5 x 10^9/L, platelets >100 x 10^9/L, Hb >9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level.
  • Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
  • Written, voluntary, informed consent.

Who cannot join

  • Previous treatment with any other investigational or not investigational agents within 28 days of first day of study drug dosing.
  • Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse.
  • Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study)
  • Severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
  • Known brain metastasis.
  • Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
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  • Known diagnosis of human immunodeficiency virus (HIV) infection.
  • Previous radiotherapy to >=25 % of the bone marrow.
  • Major surgery within 2 weeks prior to study entry.
  • Expected non-compliance to medical regimens.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Italy11 sites

  • Novartis Investigative Site

    Aviano

  • Novartis Investigative Site

    Bologna

  • Novartis Investigative Site

    Candiolo

  • Novartis Investigative Site

    Florence

  • Novartis Investigative Site

    Milan

  • Novartis Investigative Site

    Naples

  • Novartis Investigative Site

    Padova

  • Novartis Investigative Site

    Pisa

  • Novartis Investigative Site

    Roma

  • Novartis Investigative Site

    Rozzano

  • Novartis Investigative Site

    Torino

Other trials in Italy

Switzerland1 site

  • Novartis Investigative Site

    Lausanne

Other trials in Switzerland

About this study

Official title: Phase II Study of Imatinib Mesylate in Chordoma

Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in patients affected by chordoma, need to be confirmed by a Phase II study, whose primary endpoint will be the formal assessment of clinical and pathological response. Aim of the study will be to explore treatment's activity, but also the potential impact of tumor response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition, patterns of tumour response need to be investigated as well, given the peculiar patterns of response shown with molecular-targeted therapy in solid tumors.

Conditions
Chordoma
Being tested
imatinib
Keywords
chordoma, imatinib, PDGFR
Medical subject headings
Chordoma

What participants receive

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

  • imatinibDrug

Study groups in NCT00150072
Study groupRoleWhat they receive
imatinibExperimentalNot described
Receives: Drug: imatinib

What is being measured

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

  1. Tumor response

    objective response according to RECIST and clinical response

    Measured: Every 3 months for 2 years

Secondary outcomes (4)

  1. Overall survival

    from the first day of sudy treatment to the day of death for any cause

    Measured: 2 years

  2. Progression free survival

    from the first day of sudy treatment to the day of death for any cause or documented progression

    Measured: 2 years

  3. Safety and tolerability

    frequency of adverse events, abnormal lab values, bone pain, use of analgesic medication

    Measured: 2 years

  4. proportion of patients undergoing complete surgery

    number of pts undergoing complete surgery vs the one of pts not amenable to complete surgery at enrolment

    Measured: 2 years

Timeline

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

  1. First posted8 Sep 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionApr 2008
  4. Study completionApr 2008

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
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00150072
Sponsor's protocol ID
CSTI571BIT15
Status last verified
Feb 2017
First submitted
7 Sep 2005
Last updated
23 Feb 2017
Results posted
No

Publications

  • Koren-Michowitz M, le Coutre P, Duyster J, Scheid C, Panayiotidis P, Prejzner W, Rowe JM, Schwarz M, Goldschmidt N, Nagler A. Activity and tolerability of nilotinib: a retrospective multicenter analysis of chronic myeloid leukemia patients who are imatinib resistant or intolerant. Cancer. 2010 Oct 1;116(19):4564-72. doi: 10.1002/cncr.25351.

    PubMed 20572041

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing imatinib in people with Chordoma, run by Novartis Pharmaceuticals at 12 sites in 2 countries.

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 10 inclusion and 10 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: finished, as of the sponsor's last update on 23 Feb 2017. 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, Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor response (time frame: Every 3 months for 2 years). 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 NCT00150072, which also lists 1 linked publication.

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 23 Feb 2017.

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