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: March 18, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention Phase
Solid Tumors and Advanced Endometrial Cancer
Endometrial Cancer
Second-line Treatment
VEGF
Drug: TKI258
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 'UNK' or discontinued before 18 weeks of observation without progression were counted as "failure".


Secondary Outcome Measures:
  • 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.


Enrollment: 53
Study Start Date: November 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Drug: TKI258
Other Name: dovitinib

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379534

  Show 45 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01379534     History of Changes
Other Study ID Numbers: CTKI258A2211, 2011-000266-35
Study First Received: June 6, 2011
Results First Received: March 18, 2015
Last Updated: March 18, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Germany: Federal Institutes for Drugs and Medical Devices (BfArM)
Netherlands: Medicines Evaluation Board
Singapore: Health Science Authority
Italy: Italian Medicines Agency (AIFA)

Keywords provided by Novartis:
Solid tumors,
advanced endometrial cancer,
Endometrial Cancer,
Second-line treatment,
VEGF,
Neoplasms,
Endometrial Neoplasms,
Uterine Neoplasms,
Female Genital Neoplasms,
Cancer,
Carcinoma,
Uterine Diseases,
Female Genital Diseases,
Tumors,
Oral Administration,
Capsules,
Tablets,
CHIR258,
CHIR-258,
CHIR 258,
TKI258,
TKI-258,
TKI 258

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on April 26, 2015