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Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma (PACSA (ORL02))

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ClinicalTrials.gov Identifier: NCT02393820
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief 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).

Condition or disease Intervention/treatment Phase
Salivary Gland Carcinoma Drug: pazopanib Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Actual Study Start Date : August 26, 2013
Actual Primary Completion Date : December 31, 2015
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Pazopanib

Arm Intervention/treatment
Experimental: pazopanib
Pazopanib per os, 800mg daily until progression
Drug: pazopanib
treatment will be given until progression or unacceptable toxicity .
Other Name: Votrient




Primary Outcome Measures :
  1. progression free survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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:

  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393820


Locations
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France
Institut de Cancérologie de l'Ouest Paul Papin
Angers, France, 49933
CHU Bordeaux
Bordeaux, France, 33075
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Georges François Leclerc
Dijon, France, 21079
Centre Oscar Lambret
Lille, France, 59020
Centre Léon Bérard
Lyon, France, 69373
Centre Val d'Aurelle Paul Lamarque
Montpellier, France, 34298
Centre Antoine Lacassagne
Nice, France, 06189
Institut Curie
Paris, France, 75231
Centre Hospitalier St Joseph
Paris, France, 75674
Centre Eugène Marquis
Rennes, France, 35042
Institut Curie site St Cloud
Saint Cloud, France, 92210
Institut Cancérologie de l'Ouest
Saint-herblain, France, 48805
Centre Paul Strauss
Strasbourg, France, 67065
Gustave Roussy
Villejuif, France, 94
Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Joel Mr Guigay, Pr Centre Lacassagne Nice

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02393820     History of Changes
Other Study ID Numbers: UC-0130/1205
2012-004408-36 ( EudraCT Number )
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data (IPD) will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Additional relevant MeSH terms:
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Carcinoma
Salivary Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases