Phase 2
N=53
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
Solid Tumors and Advanced Endometrial Cancer · Endometrial Cancer · Second-line Treatment · VEGF
Bottom Line
View on ClinicalTrials.gov: NCT01379534 ↗Enrolled (actual)
53
Serious AEs
56.6%
Results posted
Mar 2015
Primary outcome: Primary: Progression Free Survival (PFS) Rate — 31.8; 29.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TKI258 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Rate |
31.8; 29.0 | — |
| SECONDARY Overall Response Rate (ORR) |
4.5; 16.1 | — |
| SECONDARY Disease Control Rate (DCR) |
63.6; 51.6 | — |
| SECONDARY Duration of Response (DR) |
— | — |
| SECONDARY Overall Survival (OS) |
20.2; 9.3 | — |
| SECONDARY Progression Free Survival (PFS) |
4.1; 2.7 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Deaths |
22; 31; 10; 20; 1; 4 | — |
Summary
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.
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
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
Data sourced from ClinicalTrials.gov (NCT01379534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.