This trial is active, not recruiting.

Conditions solid tumors and advanced endometrial cancer, endometrial cancer, second-line treatment, vegf
Treatment tki258
Phase phase 2
Sponsor Novartis Pharmaceuticals
Start date November 2011
End date May 2014
Trial size 53 participants
Trial identifier NCT01379534, 2011-000266-35, CTKI258A2211


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
tki258 dovitinib

Primary Outcomes

the antitumor activity of TKI258, as measured by an 18-week progression free survival rate
time frame: up to 18 weeks after the first dose of study drug

Secondary Outcomes

overall response rate (ORR)
time frame: baseline and every 6 weeks until disease progression
disease control rate (DCR)
time frame: baseline and every 6 weeks until disease progression
characterize the safety and tolerability of TKI258
time frame: up to 30 days after the last dose of study drug

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Novartis.