Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma

Last updated: October 25, 2019
Sponsor: UNICANCER
Overall Status: Completed

Phase

2

Condition

Carcinoma

Treatment

N/A

Clinical Study ID

NCT02393820
UC-0130/1205
2012-004408-36
  • Ages > 18
  • All Genders

Study Summary

Open-label, multicenter, single arm phase II study, set up in collaboration with the "Réseau d'Expertise Français sur les Cancers ORL Rares" (REFCOR), evaluating the activity and safety of single agent pazopanib in recurrent or metastatic tumors in salivary gland including adenoid cystic carcinoma (ACC) and to exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).

  • Progressive disease within 6 months before inclusion as assessed by CT and/or MRIusing at least two measurements (RECIST v1.0) with at least one measurable targetlesion >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 weeksbetween any chemotherapy, radiotherapy, surgery and study enrollment.

  • Tumoral tissue must be provided for subsequent histological review and biomarkeranalysis.

  • Euthyroid patient.

  • Hepatic, renal, cardiac and hematology normal functions.

  • Ability to take oral medication.

Exclusion

Exclusion Criteria:

  • Non salivary gland carcinoma (lachrymal gland tumor is excluded).

  • Known or symptomatic cerebral metastasis.

  • Patients treated with strong inhibitor or inductor of CYP3A4 within 14 days beforeinclusion.

  • Presence of uncontrolled infection.

  • Diagnosis of any previous malignancy within the last 5 years, except for completelyresected non-melanomatous skin carcinoma or successfully treated in situ carcinoma.

  • Stable disease.

  • Corrected QT interval (QTc) >480 msecs using Bazett's formula.

Study Design

Total Participants: 72
Study Start date:
August 26, 2013
Estimated Completion Date:
October 31, 2019

Study Description

In the non-ACC SGCHN population, assessment of the activity of pazopanib is exploratory without a predetermined study design, with up to 20 patients. A planned interim analysis of acute toxicities was conducted 3 months after the 14th non-ACC inclusion.

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.

Connect with a study center

  • Institut de Cancérologie de l'Ouest Paul Papin

    Angers, 49933
    France

    Site Not Available

  • CHU Bordeaux

    Bordeaux, 33075
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand, 63011
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59020
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon, 69373
    France

    Site Not Available

  • Centre Val d'Aurelle Paul Lamarque

    Montpellier, 34298
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Centre Hospitalier St Joseph

    Paris, 75674
    France

    Site Not Available

  • Institut Curie

    Paris, 75231
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes, 35042
    France

    Site Not Available

  • Institut Curie site St Cloud

    Saint Cloud, 92210
    France

    Site Not Available

  • Institut Cancérologie de l'Ouest

    Saint-herblain, 48805
    France

    Site Not Available

  • Centre Paul Strauss

    Strasbourg, 67065
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94
    France

    Site Not Available

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