Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-02-09 @ 1:00 AM
Study NCT ID:
NCT02203760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-15
First Post:
2014-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pazopanib Vs. Pazopanib Plus Gemcitabine
Sponsor:
North Eastern German Society of Gynaecological Oncology
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PazoDoble
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-003810-15 | EUDRACT_NUMBER | None | View |