Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
PACSA-ORL02
Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
2 other identifiers
interventional
72
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2013
Longer than P75 for phase_2
15 active sites
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
August 26, 2013
CompletedFirst Submitted
Initial submission to the registry
March 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedOctober 29, 2019
October 1, 2019
2.3 years
March 13, 2015
October 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
progression free survival
6 months
Study Arms (1)
pazopanib
EXPERIMENTALPazopanib per os, 800mg daily until progression
Interventions
treatment will be given until progression or unacceptable toxicity .
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of recurrent and/or metastatic salivary glands (including ACC and non ACC).
- 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.
You may not qualify if:
- Non salivary gland carcinoma (lachrymal gland tumor is excluded).
- Known or symptomatic cerebral metastasis.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (15)
Institut de Cancérologie de l'Ouest Paul Papin
Angers, 49933, France
CHU Bordeaux
Bordeaux, 33075, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Georges François Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
Institut Curie
Paris, 75231, France
Centre Hospitalier St Joseph
Paris, 75674, France
Centre Eugène Marquis
Rennes, 35042, France
Institut Curie site St Cloud
Saint-Cloud, 92210, France
Institut Cancérologie de l'Ouest
Saint-Herblain, 48805, France
Centre Paul Strauss
Strasbourg, 67065, France
Gustave Roussy
Villejuif, 94, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joel Mr Guigay, Pr
Centre Lacassagne Nice
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2015
First Posted
March 19, 2015
Study Start
August 26, 2013
Primary Completion
December 31, 2015
Study Completion
October 1, 2019
Last Updated
October 29, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
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.