Trial · NCT01379534

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, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-03-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT01379534. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01379534

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT01379534
Status: Completed
Phases: Phase 2
Enrollment: 53 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Solid Tumors and Advanced Endometrial Cancer, Endometrial Cancer, Second-line Treatment, VEGF
Interventions: TKI258
First posted: 2011-06-23
Last updated: 2015-05-20
Other registries' IDs: eudract:2011-000266-35
Results first posted: 2015-03-31

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS) Rate	up to 18 weeks	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.
Secondary	Overall Response Rate (ORR)	Baseline and every 6 weeks until disease progression, up to 18 weeks	ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
Secondary	Disease Control Rate (DCR)	Baseline and every 6 weeks until disease progression, up to 18 weeks	DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
Secondary	Duration of Response (DR)	up to 18 weeks	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.
Secondary	Overall Survival (OS)	up to 18 weeks	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.
Secondary	Progression Free Survival (PFS)	up to 18 weeks	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.
Secondary	Number of Participants With Adverse Events, Serious Adverse Events and Deaths	up to 30 days after the last dose of study drug, up to 18 weeks	Adverse event monitoring was conducted throughout the study.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS) Rate	up to 18 weeks	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.	Percentage of participants	NUMBER
SECONDARY	Overall Response Rate (ORR)	Baseline and every 6 weeks until disease progression, up to 18 weeks	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.	Percentage of participants	NUMBER
SECONDARY	Disease Control Rate (DCR)	Baseline and every 6 weeks until disease progression, up to 18 weeks	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.	Percentage of participants	NUMBER
SECONDARY	Duration of Response (DR)	up to 18 weeks	This outcome measure was not analyzed. The analysis was not required because there were too few responders.
SECONDARY	Overall Survival (OS)	up to 18 weeks	Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.	Months	MEDIAN
SECONDARY	Progression Free Survival (PFS)	up to 18 weeks	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.	Months	MEDIAN
SECONDARY	Number of Participants With Adverse Events, Serious Adverse Events and Deaths	up to 30 days after the last dose of study drug, up to 18 weeks	Safety analysis set: The safety set included all participants who received at least one dose of study medication.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS) Rate	FGFR2 (MUT)	31.8		Percentage of participants
Progression Free Survival (PFS) Rate	FGFR2 (WT)	29.0		Percentage of participants
Overall Response Rate (ORR)	FGFR2 (MUT)	4.5		Percentage of participants
Overall Response Rate (ORR)	FGFR2 (WT)	16.1		Percentage of participants
Disease Control Rate (DCR)	FGFR2 (MUT)	63.6		Percentage of participants
Disease Control Rate (DCR)	FGFR2 (WT)	51.6		Percentage of participants
Overall Survival (OS)	FGFR2 (MUT)	20.2	95% Confidence Interval 8.2 to 20.2	Months
Overall Survival (OS)	FGFR2 (WT)	9.3	95% Confidence Interval 6.0 to 15.2	Months
Progression Free Survival (PFS)	FGFR2 (MUT)	4.1	95% Confidence Interval 2.6 to 5.5	Months
Progression Free Survival (PFS)	FGFR2 (WT)	2.7	95% Confidence Interval 1.4 to 6.8	Months

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Phase	STARTED	FGFR2 (MUT)	22
Treatment Phase	STARTED	FGFR2 (WT)	31
Treatment Phase	COMPLETED	FGFR2 (MUT)	0
Treatment Phase	COMPLETED	FGFR2 (WT)	0
Treatment Phase	NOT COMPLETED	FGFR2 (MUT)	22
Treatment Phase	NOT COMPLETED	FGFR2 (WT)	31
Tumor Assessment Follow-up (f/u) Phase	STARTED	FGFR2 (MUT)	4
Tumor Assessment Follow-up (f/u) Phase	STARTED	FGFR2 (WT)	2
Tumor Assessment Follow-up (f/u) Phase	COMPLETED	FGFR2 (MUT)	0
Tumor Assessment Follow-up (f/u) Phase	COMPLETED	FGFR2 (WT)	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events296

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	ANAEMIA	Blood and lymphatic system disorders	FGFR2 (MUT)	3	22
other	ANAEMIA	Blood and lymphatic system disorders	FGFR2 (WT)	10	31
other	LEUKOPENIA	Blood and lymphatic system disorders	FGFR2 (MUT)	0	22
other	LEUKOPENIA	Blood and lymphatic system disorders	FGFR2 (WT)	2	31
other	LYMPHOPENIA	Blood and lymphatic system disorders	FGFR2 (MUT)	1	22
other	LYMPHOPENIA	Blood and lymphatic system disorders	FGFR2 (WT)	3	31
other	NEUTROPENIA	Blood and lymphatic system disorders	FGFR2 (MUT)	1	22
other	NEUTROPENIA	Blood and lymphatic system disorders	FGFR2 (WT)	2	31
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	FGFR2 (MUT)	0	22
other	THROMBOCYTOPENIA	Blood and lymphatic system disorders	FGFR2 (WT)	4	31

1 to 10 of 296Source ClinicalTrials.gov

See all 296 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	FGFR2 (MUT)
Total, all-cause mortality	FGFR2 (WT)
Total, other adverse events	FGFR2 (MUT)	21	22
Total, other adverse events	FGFR2 (WT)	31	31
Total, serious adverse events	FGFR2 (MUT)	10	22
Total, serious adverse events	FGFR2 (WT)	20	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25981814	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
FGFR2 (MUT) vs FGFR2 (WT): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01379534

GET https://conductscience.org/api/trials/v1/NCT01379534/events?page=2

API reference For AI assistants