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

• Status: Completed
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER

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.