Salivary Gland CarcinomaPhase 2PACSA-ORL02NCT02393820
Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
A Phase 2 study testing pazopanib in people with Salivary Gland Carcinoma, run by UNICANCER at 15 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Carcinoma
- What is being tested?
- pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 15 sitesFrance
- Study dates
- 26 Aug 2013to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Institut de Cancérologie de l'Ouest Paul Papin
Angers, 49933
CHU Bordeaux
Bordeaux, 33075
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Centre Léon Bérard
Lyon, 69373
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Institut Curie
Paris, 75231
Centre Hospitalier St Joseph
Paris, 75674
Centre Eugène Marquis
Rennes, 35042
Institut Curie site St Cloud
Saint-Cloud, 92210
Institut Cancérologie de l'Ouest
Saint-Herblain, 48805
Centre Paul Strauss
Strasbourg, 67065
Gustave Roussy
Villejuif, 94
About this study
Official title: Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
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).
Read the 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.
- Conditions
- Salivary Gland Carcinoma
- Being tested
- pazopanib
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pazopanibDrug
Also called Votrient
treatment will be given until progression or unacceptable toxicity .
| Study group | Role | What they receive |
|---|---|---|
| pazopanib | Experimental | Pazopanib per os, 800mg daily until progression Receives: Drug: pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start26 Aug 2013
- Primary completion31 Dec 2015
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joel Mr Guigay, Pr, Principal investigator, Centre Lacassagne Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393820
- Sponsor's protocol ID
- UC-0130/1205
- Other IDs
- 2012-004408-36
- Acronym
- PACSA-ORL02
- Status last verified
- Oct 2019
- First submitted
- 13 Mar 2015
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma
- ClinicalTrials.gov ID
- NCT02393820
- Acronym / sponsor ID
- PACSA-ORL02 / UC-0130/1205
- Conditions
- Salivary Gland Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 26 Aug 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pazopanib | Experimental | Drug: pazopanibPazopanib per os, 800mg daily until progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pazopanibAlso: Votrienttreatment will be given until progression or unacceptable toxicity . | Drug | pazopanib |
Primary outcome
progression free survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Mr Guigay, Pr principal investigator
Centre Lacassagne Nice
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pazopanib in people with Salivary Gland Carcinoma, run by UNICANCER at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.