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Solid Tumors and Advanced Endometrial CancerPhase 2NCT01379534

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 2 study testing TKI258 in people with Solid Tumors and Advanced Endometrial Cancer and Endometrial Cancer, run by Novartis Pharmaceuticals at 45 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
TKI258
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
45 sitesin 7 countries
Study dates
Nov 2011to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

45 sites in 7 countries.

45 sites in 7 countries

United States21 sites

  • Virginia Oncology Associates VOA - Lake Wright

    *see Various Departments*, Virginia

  • Hope A Woman's Cancer Center

    Asheville, North Carolina, 28806

  • Texas Oncology, P.A. Austin

    Bedford, Texas, 76022

  • Texas Oncology, P.A. Tex Onc (3)

    Bedford, Texas, 76022

  • Dana Farber Cancer Institute SC

    Boston, Massachusetts, 02115

  • Community Oncology Research Network

    Chattanooga, Tennessee, 37403

  • Duke University Medical Center Duke3

    Durham, North Carolina, 27710

  • Texas Oncology, P.A. SC

    Fort Worth, Texas, 76104

  • St. Jude Heritage Medical Group St Jude

    Fullerton, California, 92835

  • Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

    Greenwood Village, Colorado

  • Indiana University Health Goshen Center for Cancer IU Simon Cancer

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals & Clinics SC

    Iowa City, Iowa, 52242

  • Southeast Nebraska Oncology Cancer Center

    Lincoln, Nebraska, 68510

  • USC/Kenneth Norris Comprehensive Cancer Center USC 2

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center TKI258A2211 (SC)

    Los Angeles, California, 90048

  • University of California at Los Angeles UCLA 3

    Los Angeles, California, 90095

  • The West Clinic SC

    Memphis, Tennessee, 38120

  • University of South Alabama / Mitchell Cancer Institute Univ South Alabama

    Mobile, Alabama, 36688

  • Florida Hospital Cancer Institute FL Hosp

    Orlando, Florida, 32804

  • South Texas Oncology and Hematology, PA South Tex Onc

    San Antonio, Texas, 78258

  • Cancer Care Northwest SC

    Spokane, Washington, 99202

Other trials in United States

Italy7 sites

  • Novartis Investigative Site

    Candiolo, TO, 10060

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Roma, RM, 00168

Other trials in Italy

Spain7 sites

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Murcia, Murcia, 30008

  • Novartis Investigative Site

    Oviedo, Principality of Asturias, 33006

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

Other trials in Spain

United Kingdom4 sites

  • Novartis Investigative Site

    Glasgow, G12 0YN

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    London, NW1 2BU

  • Novartis Investigative Site

    Nottingham, NG5 1PB

Other trials in United Kingdom

Brazil3 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-270

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900

Other trials in Brazil

South Korea2 sites

  • Novartis Investigative Site

    Seoul, Korea, 135-710

  • Novartis Investigative Site

    Seoul, 738-736

Other trials in South Korea

New Zealand1 site

  • Novartis Investigative Site

    Grafton, Auckland

Other trials in New Zealand

About this study

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

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.

Being tested
TKI258
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,
Medical subject headings
Endometrial Neoplasms, Neoplasms, Uterine Neoplasms, Genital Neoplasms, Female, Carcinoma, Uterine Diseases, Genital Diseases, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TKI258Drug

    Also called dovitinib

Study groups in NCT01379534
Study groupRoleWhat they receive
TKI258Experimental1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
Receives: Drug: TKI258

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 18 weeks

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).

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

  2. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).

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

  3. Duration of Response (DR)

    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.

    Measured: up to 18 weeks

  4. Overall Survival (OS)

    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.

    Measured: up to 18 weeks

  5. Progression Free Survival (PFS)

    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.

    Measured: up to 18 weeks

  6. Number of Participants With Adverse Events, Serious Adverse Events and Deaths

    Adverse event monitoring was conducted throughout the study.

    Measured: up to 30 days after the last dose of study drug, up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01379534
Sponsor's protocol ID
CTKI258A2211
Other IDs
2011-000266-35
Status last verified
May 2015
First submitted
6 Jun 2011
Last updated
20 May 2015

Publications

  • 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.

    PubMed 25981814

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TKI258 in people with Solid Tumors and Advanced Endometrial Cancer and Endometrial Cancer, run by Novartis Pharmaceuticals at 45 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Italy, Spain, United Kingdom, Brazil and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) Rate (time frame: up to 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01379534, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.

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