EUCTR2011-000266-35-ES
Active, not recruiting
Not Applicable
A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer
ovartis Farmacéutica S.A0 sites80 target enrollmentMarch 28, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Farmacéutica S.A
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? 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
Exclusion Criteria
- •? 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
Outcomes
Primary Outcomes
Not specified
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