Pazopanib in Patients With Progressive Recurrent and/or Metastatic Salivary Gland Carcinoma (PACSA-ORL02)
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ClinicalTrials.gov Identifier: NCT02393820 |
Recruitment Status :
Completed
First Posted : March 19, 2015
Last Update Posted : October 29, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Salivary Gland Carcinoma | Drug: pazopanib | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | N/A |
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 |
Actual Study Completion Date : | October 2019 |

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 |
- progression free survival [ Time Frame: 6 months ]

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

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
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 |
Principal Investigator: | Joel Mr Guigay, Pr | Centre Lacassagne Nice |
Responsible Party: | UNICANCER |
ClinicalTrials.gov Identifier: | NCT02393820 |
Other Study ID Numbers: |
UC-0130/1205 2012-004408-36 ( EudraCT Number ) |
First Posted: | March 19, 2015 Key Record Dates |
Last Update Posted: | October 29, 2019 |
Last Verified: | October 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. |
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 |