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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01379534
First received: June 6, 2011
Last updated: April 24, 2014
Last verified: April 2014

June 6, 2011
April 24, 2014
November 2011
May 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The 18-week PFS is defined as the percentage of patients who do not have a progression event at week 18
Same as current
Complete list of historical versions of study NCT01379534 on ClinicalTrials.gov Archive Site
  • overall response rate (ORR) [ Time Frame: baseline and every 6 weeks until disease progression ] [ Designated as safety issue: No ]
    ORR is defined as percentage of patients with a best overall response of complete response (CR), partial response (PR) or progressive disease (PD)
  • disease control rate (DCR) [ Time Frame: baseline and every 6 weeks until disease progression ] [ Designated as safety issue: No ]
    DCR is defined as percentage of patients with a best overall response of CR, PR or stable disease (SD)
  • characterize the safety and tolerability of TKI258 [ Time Frame: up to 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    Safety will be measured in terms of incidence of adverse events, serious adverse events, changes from baseline in vital signs, laboratory test results, ECG and cardiac imaging
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Solid Tumors and Advanced Endometrial Cancer
  • Endometrial Cancer
  • Second-line Treatment
  • VEGF
Drug: TKI258
Other Name: dovitinib
Experimental: TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Intervention: Drug: TKI258
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Italy,   Korea, Republic of,   New Zealand,   Spain,   United Kingdom
 
NCT01379534
CTKI258A2211, 2011-000266-35
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP