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Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma (PACSA-ORL02)

Primary Purpose

Salivary Gland Carcinoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
pazopanib
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Salivary Gland Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut de Cancérologie de l'Ouest Paul Papin
  • CHU Bordeaux
  • Centre Jean Perrin
  • Centre Georges François Leclerc
  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Centre Val d'Aurelle Paul Lamarque
  • Centre Antoine Lacassagne
  • Institut Curie
  • Centre Hospitalier St Joseph
  • Centre Eugène Marquis
  • Institut Curie site St Cloud
  • Institut Cancérologie de l'Ouest
  • Centre Paul Strauss
  • Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pazopanib

Arm Description

Pazopanib per os, 800mg daily until progression

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

Full Information

First Posted
March 13, 2015
Last Updated
October 25, 2019
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT02393820
Brief Title
Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Acronym
PACSA-ORL02
Official Title
Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 26, 2013 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pazopanib
Arm Type
Experimental
Arm Description
Pazopanib per os, 800mg daily until progression
Intervention Type
Drug
Intervention Name(s)
pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
treatment will be given until progression or unacceptable toxicity .
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Mr Guigay, Pr
Organizational Affiliation
Centre Lacassagne Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Val d'Aurelle Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
Centre Hospitalier St Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Curie site St Cloud
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Institut Cancérologie de l'Ouest
City
Saint-herblain
ZIP/Postal Code
48805
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67065
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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