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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01379534
First received: June 6, 2011
Last updated: May 2, 2015
Last verified: May 2015

June 6, 2011
May 2, 2015
November 2011
March 2014   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) Rate [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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
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, up to 18 weeks ] [ Designated as safety issue: No ]
    ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
  • Disease Control Rate (DCR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ] [ Designated as safety issue: No ]
    DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
  • Duration of Response (DR) [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
    Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.
  • Overall Survival (OS) [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
    OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.
  • Progression Free Survival (PFS) [ Time Frame: up to 18 weeks ] [ Designated as safety issue: No ]
    PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.
  • Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: up to 30 days after the last dose of study drug, up to 18 weeks ] [ Designated as safety issue: Yes ]
    Adverse event monitoring was conducted throughout the study.
  • 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
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
Konecny GE, Finkler N, Garcia AA, Lorusso D, Lee PS, Rocconi RP, Fong PC, Squires M, Mishra K, Upalawanna A, Wang Y, Kristeleit R. Second-line dovitinib (TKI258) in patients with FGFR2-mutated or FGFR2-non-mutated advanced or metastatic endometrial cancer: a non-randomised, open-label, two-group, two-stage, phase 2 study. Lancet Oncol. 2015 Jun;16(6):686-94. doi: 10.1016/S1470-2045(15)70159-2. Epub 2015 May 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
March 2014
March 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Italy,   Korea, Republic of,   New Zealand,   Spain,   United Kingdom
Egypt
 
NCT01379534
CTKI258A2211, 2011-000266-35
Not Provided
Not Provided
Not Provided
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2015

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