NCT02203760

Pazopanib Vs. Pazopanib Plus Gemcitabine

Pazopanib Vs. Pazopanib Plus Gemcitabine in Patients with Relapsed or Metastatic Uterine Leiomyosarcomas or Uterine Carcinosarcomas: a Multi-center, Randomized Phase-II Clinical Trial of the NOGGO and AGO - PazoDoble -

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, open-label, multicenter phase II trial in order to determine progression-free survival of patients with refractory or relapsed metastatic uterine leiomyosarcomas or other metastatic uterine tumours.

Detailed description

Study design: This study is a prospective, randomized, open-label, multicenter phase II trial in order to determine progression-free survival of patients with refractory or relapsed metastatic uterine leiomyosarcomas or other metastatic uterine tumours. Indication: Relapsed or metastatic uterine leiomyosarcomas or carcinosarcomas Randomization: Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the following therapy * Arm A: Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or * Arm B: Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be treated according to Arm A. Planned number of patients: 87 patients with uterine leiomyosarcomas 20 patients with uterine carcinosarcomas Treatment schedules: Patients with uterine leiomyosarcomas will be randomized in a 1:1-fashion to receive the following therapy • Arm A (experimental arm / combination arm): Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or • Arm B (control arm / monotherapy arm): Pazopanib 800 mg orally once daily Patients with uterine carcinosarcomas will be treated according to Arm A. Planned treatment duration per subject: Patients continue on study treatment until disease progression, death, unacceptable toxicity or withdrawal of consent for any reason.

Conditions

• Leiomyosarcoma or Carcinosarcoma

Interventions

Type	Name	Description
DRUG	Pazopanib plus Gemcitabine	Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
DRUG	Pazopanib	Pazopanib 800 mg orally once daily

Timeline

• Start date: 2019-10-16
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2014-07-30
• Last updated: 2024-11-15

Locations

9 sites across 1 country: Germany