A trial investigating the efficacy of TKI258 in patients with cancer of the endometrium that has progressed after prior therapy
- Conditions
- Advanced and/or metastatic endometrial carcinomaMedDRA version: 20.0 Level: PT Classification code 10014736 Term: Endometrial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000266-35-GB
- Lead Sponsor
- ovartis Pharma Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 53
• Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy)
• Female patients >= 18 years old
• Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease
• ECOG (Eastern Cooperative Oncology Group) performance status = 2
• At least one measurable lesion as per RECIST
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
• Previous treatment with an FGFR inhibitor
• More than one line of treatment for advanced or metastatic disease
• Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors
• Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery
• Known central nervous system (CNS) metastases
• Malignancy within 3 years of study enrollment
Other protocol-defined exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method