NCT00150072

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

3.5 years

First QC Date

September 7, 2005

Last Update Submit

February 21, 2017

Conditions

Chordoma

Keywords

chordomaimatinibPDGFR

Outcome Measures

Primary Outcomes (1)

  • Tumor response

    objective response according to RECIST and clinical response

    Every 3 months for 2 years

Secondary Outcomes (4)

  • Overall survival

    2 years

  • Progression free survival

    2 years

  • Safety and tolerability

    2 years

  • proportion of patients undergoing complete surgery

    2 years

Study Arms (1)

imatinib

EXPERIMENTAL
Drug: imatinib

Interventions

imatinibDRUG
imatinib

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Novartis Investigative Site

Aviano, Italy

Location

Novartis Investigative Site

Bologna, Italy

Location

Novartis Investigative Site

Candiolo, Italy

Location

Novartis Investigative Site

Florence, Italy

Location

Novartis Investigative Site

Milan, Italy

Location

Novartis Investigative Site

Napoli, Italy

Location

Novartis Investigative Site

Padua, Italy

Location

Novartis Investigative Site

Pisa, Italy

Location

Novartis Investigative Site

Roma, Italy

Location

Novartis Investigative Site

Rozzano, Italy

Location

Novartis Investigative Site

Torino, Italy

Location

Novartis Investigative Site

Lausanne, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 20572041RESULT

MeSH Terms

Conditions

Chordoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

October 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

CH(1)IT(11)