A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | November 2011 |
| End Date: | July 2016 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | 1-888-669-6682 |
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
This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study
to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either
FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.
to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either
FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.
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
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
inclusion/exclusion criteria may apply
We found this trial at
34
sites
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