Trial · NCT02347332

Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer

NCT02347332, Phase 3, Completed, Pierre Fabre Medicament; results first posted 2019-02-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer. Trials, record NCT02347332. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02347332

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Trial

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

Title: Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
NCT number: NCT02347332
Status: Completed
Phases: Phase 3
Enrollment: 459 participants, actual
Lead sponsor: Pierre Fabre Medicament
Conditions: Recurrent or Metastatic Head and Neck Carcinoma
Interventions: Vinflunine, Methotrexate
First posted: 2015-01-27
Last updated: 2019-03-05
Results first posted: 2019-02-04
Limitations and caveats: Sponsor ended recrutement and decided to limit analysis of efficacy.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Survival in the ITT Population (Months)	Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months	Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.
Secondary	Progression Free Survival	an expected average of 4 months	Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)
Secondary	Objective Response Rate (ORR)	6 weeks	The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.
Secondary	Disease Control Rate	30 months	Percentage of best overall responses CR, PR and SD in the analysed population
Secondary	Duration of Response	30 months	Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival in the ITT Population (Months)	Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months	ITT population	Months	MEDIAN
SECONDARY	Progression Free Survival	an expected average of 4 months	ITT	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR)	6 weeks		Percent of participants	MEDIAN
SECONDARY	Disease Control Rate	30 months		% patients	MEDIAN
SECONDARY	Duration of Response	30 months	ITT	Months	MEDIAN

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Overall Survival in the ITT Population (Months)	Vinflunine Plus Methotrexate	7.1	95% Confidence Interval 5.7 to 8.4	Months
Overall Survival in the ITT Population (Months)	Methotrexate	6.8	95% Confidence Interval 6.1 to 8.0	Months
Progression Free Survival	Vinflunine Plus Methotrexate	2.8	95% Confidence Interval 2.6 to 3.3	Months
Progression Free Survival	Methotrexate	2.8	95% Confidence Interval 2.1 to 3.1	Months
Objective Response Rate (ORR)	Vinflunine Plus Methotrexate	17.8	95% Confidence Interval 13.1 to 23.4	Percent of participants
Objective Response Rate (ORR)	Methotrexate	14.8	95% Confidence Interval 10.5 to 20.1	Percent of participants
Disease Control Rate	Vinflunine Plus Methotrexate	50.9	95% Confidence Interval 44.2 to 57.5	% patients
Disease Control Rate	Methotrexate	46.3	95% Confidence Interval 39.7 to 53.0	% patients
Duration of Response	Vinflunine Plus Methotrexate	4.2	95% Confidence Interval 2.5 to 5.6	Months
Duration of Response	Methotrexate	4.2	95% Confidence Interval 2.7 to 5.1	Months

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Vinflunine Plus Methotrexate	230
Overall Study	STARTED	Methotrexate	229
Overall Study	COMPLETED	Vinflunine Plus Methotrexate	0
Overall Study	COMPLETED	Methotrexate	0
Overall Study	NOT COMPLETED	Vinflunine Plus Methotrexate	230
Overall Study	NOT COMPLETED	Methotrexate	229

Source ClinicalTrials.gov

Adverse events84

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	Events
other	Weight decreased	Investigations	Vinflunine Plus Methotrexate	69	225	248
other	Weight decreased	Investigations	Methotrexate	63	227	150
other	Creatinine renal clearance decreased	Investigations	Vinflunine Plus Methotrexate	17	225	49
other	Creatinine renal clearance decreased	Investigations	Methotrexate	10	227	28
other	Weight increased	Investigations	Vinflunine Plus Methotrexate	12	225	47
other	Weight increased	Investigations	Methotrexate	15	227	227
other	Alanine aminotransferase increased	Investigations	Vinflunine Plus Methotrexate	11	225	26
other	Alanine aminotransferase increased	Investigations	Methotrexate	28	227	74
other	Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Vinflunine Plus Methotrexate	20	225	58
other	Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Methotrexate	12	227	29

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vinflunine Plus Methotrexate	185	225
Total, all-cause mortality	Methotrexate	194	227
Total, other adverse events	Vinflunine Plus Methotrexate	211	225
Total, other adverse events	Methotrexate	213	227
Total, serious adverse events	Vinflunine Plus Methotrexate	106	225
Total, serious adverse events	Methotrexate	81	227

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Vinflunine Plus Methotrexate vs Methotrexate: deaths from any cause	Trial comparisons
Vinflunine Plus Methotrexate vs Methotrexate: serious adverse events	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/NCT02347332

GET https://conductscience.org/api/trials/v1/NCT02347332/events?page=2

API reference For AI assistants