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

Salivary Gland Carcinoma Clinical Trial

— PACSA-ORL02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393820
• Other study ID #: UC-0130/1205
• Secondary ID: 2012-004408-36
• Status: Completed
• Phase: Phase 2
• Start date: August 26, 2013
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 exploring the activity and safety of pazopanib in non-adenoid cystic carcinoma (non-ACC).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2019
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Salivary Gland Carcinoma
• Salivary Gland Neoplasms

Intervention

Drug:
• pazopanib
treatment will be given until progression or unacceptable toxicity .

Locations

Country	Name	City	State
France	Institut de Cancérologie de l'Ouest Paul Papin	Angers
France	CHU Bordeaux	Bordeaux
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Centre Val d'Aurelle Paul Lamarque	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Centre Hospitalier St Joseph	Paris
France	Institut Curie	Paris
France	Centre Eugène Marquis	Rennes
France	Institut Curie site St Cloud	Saint Cloud
France	Institut Cancérologie de l'Ouest	Saint-herblain
France	Centre Paul Strauss	Strasbourg
France	Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		6 months