Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Endometrial Neoplasms

Genital Diseases, Female

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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

TKI258

Novartis Pharmaceuticals

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.

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

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.

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

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

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.

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.

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.

Adverse event monitoring was conducted throughout the study.

Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.

FGFR2 (MUT)

FGFR2 (WT)

Total

Age, Continuous

Sex/Gender, Customized

Study Director

Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.

Progression Free Survival (PFS) Rate

Overall Response Rate (ORR)

Disease Control Rate (DCR)

This outcome measure was not analyzed. The analysis was not required because there were too few responders.

Duration of Response (DR)

Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.

Overall Survival (OS)

Progression Free Survival (PFS)

Adverse events (serious and non-serious)

Serious adverse events

Deaths

Safety analysis set: The safety set included all participants who received at least one dose of study medication.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	Solid Tumors an... Endometrial Can... Second-line Tre... VEGF	TKI258	18 Years -	Novartis
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	Solid Tumors an... Endometrial Can... Second-line Tre... VEGF	TKI258	18 Years -	Novartis

Spots Global Cancer Trial Database for female genital diseases,