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 currently recruiting participants.
Verified March 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01379534
First received: June 6, 2011
Last updated: March 13, 2014
Last verified: March 2014
  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: 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:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01379534

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 60 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
Last Updated: March 13, 2014
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
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors

ClinicalTrials.gov processed this record on April 16, 2014