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

NCT01379534 | Completed Phase 2 Results

• 2 other identifiers: CTKI258A22112011-000266-35
• Study Type: interventional
• Target: 53
• Locations: 7 countries
• Sites: 45

Brief Summary

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.

Conditions

Solid Tumors and Advanced Endometrial Cancer; Endometrial Cancer; Second-line Treatment; VEGF

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Rate

  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.

  up to 18 weeks

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  Baseline and every 6 weeks until disease progression, up to 18 weeks

• Disease Control Rate (DCR)

  Baseline and every 6 weeks until disease progression, up to 18 weeks

• Duration of Response (DR)

  up to 18 weeks

• Overall Survival (OS)

  up to 18 weeks

• Progression Free Survival (PFS)

  up to 18 weeks

Study Arms (1)

TKI258

EXPERIMENTAL

1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status

Drug: TKI258

Interventions

TKI258 DRUG

Also known as: dovitinib

TKI258

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (45)

University of South Alabama / Mitchell Cancer Institute Univ South Alabama

Mobile, Alabama, 36688, United States

Location

St. Jude Heritage Medical Group St Jude

Fullerton, California, 92835, United States

Location

USC/Kenneth Norris Comprehensive Cancer Center USC 2

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center TKI258A2211 (SC)

Los Angeles, California, 90048, United States

Location

University of California at Los Angeles UCLA 3

Los Angeles, California, 90095, United States

Location

Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

Greenwood Village, Colorado, United States

Location

Florida Hospital Cancer Institute FL Hosp

Orlando, Florida, 32804, United States

Location

Indiana University Health Goshen Center for Cancer IU Simon Cancer

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals & Clinics SC

Iowa City, Iowa, 52242, United States

Location

Dana Farber Cancer Institute SC

Boston, Massachusetts, 02115, United States

Location

Southeast Nebraska Oncology Cancer Center

Lincoln, Nebraska, 68510, United States

Location

Hope A Woman's Cancer Center

Asheville, North Carolina, 28806, United States

Location

Duke University Medical Center Duke3

Durham, North Carolina, 27710, United States

Location

Community Oncology Research Network

Chattanooga, Tennessee, 37403, United States

Location

The West Clinic SC

Memphis, Tennessee, 38120, United States

Location

Texas Oncology, P.A. Austin

Bedford, Texas, 76022, United States

Location

Texas Oncology, P.A. Tex Onc (3)

Bedford, Texas, 76022, United States

Location

Texas Oncology, P.A. SC

Fort Worth, Texas, 76104, United States

Location

South Texas Oncology and Hematology, PA South Tex Onc

San Antonio, Texas, 78258, United States

Location

Virginia Oncology Associates VOA - Lake Wright

*see Various Departments*, Virginia, United States

Location

Cancer Care Northwest SC

Spokane, Washington, 99202, United States

Location

Novartis Investigative Site

Belo Horizonte, Minas Gerais, 30150-270, Brazil

Location

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Novartis Investigative Site

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Monza, MB, 20900, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Milan, MI, 20141, Italy

Location

Novartis Investigative Site

Pisa, PI, 56126, Italy

Location

Novartis Investigative Site

Roma, RM, 00168, Italy

Location

Novartis Investigative Site

Candiolo, TO, 10060, Italy

Location

Novartis Investigative Site

Grafton, Auckland, New Zealand

Location

Novartis Investigative Site

Seoul, Korea, 135-710, South Korea

Location

Novartis Investigative Site

Seoul, 738-736, South Korea

Location

Novartis Investigative Site

Córdoba, Andalusia, 14004, Spain

Location

Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

Location

Novartis Investigative Site

Sabadell, Barcelona, 08208, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Majadahonda, Madrid, 28222, Spain

Location

Novartis Investigative Site

Murcia, Murcia, 30008, Spain

Location

Novartis Investigative Site

Oviedo, Principality of Asturias, 33006, Spain

Location

Novartis Investigative Site

Glasgow, G12 0YN, United Kingdom

Location

Novartis Investigative Site

Leeds, LS9 7TF, United Kingdom

Location

Novartis Investigative Site

London, NW1 2BU, United Kingdom

Location

Novartis Investigative Site

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25981814 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Carcinoma; Uterine Diseases; Genital Diseases, Female

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 23, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 20, 2015
• Results First Posted: March 31, 2015

Record last verified: 2015-05

Locations

GB (4); BR (3); KR (2); IT (7); ES (7); NZ (1); US (21)