Pazopanib Vs. Pazopanib Plus Gemcitabine (NCT02203760) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pazopanib Vs. Pazopanib Plus Gemcitabine
Germany58 participantsStarted 2019-10-16
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects must provide informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol
✓. Histologically or cytological confirmed uterine leiomyosarcoma or uterine carcinosarcoma including any subtypes
✓. Patients with a contraindication for doxorubicin OR patients must have received prior chemotherapies
✓. For patients with prior anthracycline therapy normal cardiac function with LVEF at least 50% must be assessed by quantitative echocardiogram or MUGA scan
✓. Prior Gemcitabine containing chemotherapy is permitted provided that at least 8 weeks have elapsed since the last dose of therapy
✓. ECOG performance status 0-1
✓. At least 18 years old
✓. Measurable disease according to RECIST v 1.1 criteria (in case of tumour debulking - staging CT-scan after surgery)
Exclusion criteria
✕. Prior malignancy
✕. Patient has received prior treatment with any anti-angiogenic agent including bevacizumab and tyrosine kinase inhibitors
✕. Active malignancy or any malignancy in the last 5 years prior to first dose of study drug other than LMS and CS
What they're measuring
1
Progression free survival assessed as rate of patients without progression Second malignancy or clinical progression - patients with unknown or missing PFS will be treated as non-responder
Timeframe: 6 months
Trial details
NCT IDNCT02203760
SponsorNorth Eastern German Society of Gynaecological Oncology
✕. History or clinical evidence of central nervous system (CNS) or leptomeningeal metastases, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) is required only if clinically indicated or if the subject has a history of CNS metastases
✕. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
✕. Corrected QT interval (QTc) \> 450 Milliseconds using Barzett's formula
✕. History of any one or more of the following cardiovascular conditions within the past 6 months:
✕. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.