Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
NCT ID: NCT02393820
Last Updated: 2019-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2013-08-26
2019-10-31
Brief Summary
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Detailed Description
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ACC As the endpoint will be evaluated at 6 months after treatment start, a one-stage phase II study design was chosen. The unacceptable 6-month rate of progression free survival is 20% and the promising 6-month rate of progression free survival is 40%.
43 patients are to be treated. If ≤12 patients alive without progression at 6 months will be observed, the drug will be declared ineffective.
If ≥13 patients alive without progression at 6 months will be observed, the drug will be declared promising.
The α error rate (accepting a poor treatment) is 0.07 and the β error rate (rejecting a promising treatment) is 0.07.
Analysis of results will be separated between non ACC and ACC.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pazopanib
Pazopanib per os, 800mg daily until progression
pazopanib
treatment will be given until progression or unacceptable toxicity .
Interventions
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pazopanib
treatment will be given until progression or unacceptable toxicity .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Progressive disease within 6 months before inclusion as assessed by CT and/or MRI using at least two measurements (RECIST v1.0) with at least one measurable target lesion \>10 mm.
* Recurrent and/or metastatic salivary glands carcinoma failing locoregional therapy, without possibility of curative treatment.
* Patients may have had unlimited prior therapy but must have had at least 4 weeks between any chemotherapy, radiotherapy, surgery and study enrollment.
* Tumoral tissue must be provided for subsequent histological review and biomarker analysis.
* Euthyroid patient.
* Hepatic, renal, cardiac and hematology normal functions.
* Ability to take oral medication.
Exclusion Criteria
* Known or symptomatic cerebral metastasis.
* Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days before inclusion.
* Presence of uncontrolled infection.
* Diagnosis of any previous malignancy within the last 5 years, except for completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.
* Stable disease.
* Corrected QT interval (QTc) \>480 msecs using Bazett's formula.
18 Years
ALL
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Joel Mr Guigay, Pr
Role: PRINCIPAL_INVESTIGATOR
Centre Lacassagne Nice
Locations
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Institut de Cancérologie de l'Ouest Paul Papin
Angers, , France
CHU Bordeaux
Bordeaux, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges François Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Léon Bérard
Lyon, , France
Centre Val d'Aurelle Paul Lamarque
Montpellier, , France
Centre Antoine Lacassagne
Nice, , France
Institut Curie
Paris, , France
Centre Hospitalier St Joseph
Paris, , France
Centre Eugène Marquis
Rennes, , France
Institut Curie site St Cloud
Saint-Cloud, , France
Institut Cancérologie de l'Ouest
Saint-Herblain, , France
Centre Paul Strauss
Strasbourg, , France
Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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2012-004408-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UC-0130/1205
Identifier Type: -
Identifier Source: org_study_id
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