Clinical Trial VICCGYN1174
Title
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
Principal Investigator(s)
Details
- Protocol No. VICCGYN1174
- Open Date: 09/26/2012
- Staging: Phase II
- Age Group: Adults
- Scope: National
- Objective: To assess the antitumor activity of TKI258, as measured by an 18-week progression free survival (PFS) rate (based on local investigators assessment according to RECIST v.1.1), in patients with pre-treated endometrial cancer (i.e., 1 prior line of therapy for advanced and/or metastatic disease), with or without FGFR2 mutation.
- Disease Sites: Uterine
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: TKI258
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01379534
- Secondary Protocol No: CTKI258A2211
Description
The purpose of this study is to find out if the study drug TKI258 has a positive effect in women with advanced endometrial cancer. This study is designed to test the effectiveness of TKI258 when given to women with advanced endometrial cancer. The study will also look to: Determine whether the disease has improved, remained stable, or worsened Determine the side effects of oral TKI258 - how often they occur, how serious they are, and how long they last Determine the amount of TKI258 in the blood- this is called pharmacokinetics (PK) which is looking at what your body does to the drug. Determine the changes that can be seen before and after taking TKI258 in your blood - this is called pharmacodynamics (PD) which is looking at what the drug does to your body Determine the relationship between PK and PD
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
Learn More
- Call toll-free number: 1-800-811-8480
- Use our Online self–referral form
- Print this page for your doctor
You do not have JavaScript enabled. This site works better with JavaScript turned on.
