Trial · NCT00727506

BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma

NCT00727506, Phase 2, Completed, Boehringer Ingelheim; results first posted 2014-01-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma. Trials, record NCT00727506. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00727506

On this page

Trial

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

Title: BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma
NCT number: NCT00727506
Status: Completed
Phases: Phase 2
Enrollment: 151 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Glioma
Interventions: BIBW 2992, TMZ, BIBW 2992 plus TMZ
First posted: 2008-08-04
Last updated: 2017-08-15
Results first posted: 2014-01-24

Source ClinicalTrials.gov

Registered outcomes31

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

List	Outcome	Time frame	Description
Primary	Number of Participants With DLT- Phase I	From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days	Number of Participants With Dose Limiting Toxicities (DLT) - Phase I Part
Primary	Progression-free Survival (PFS-6) at Six Months - Phase II	At six months after randomization	PFS-6 is defined as probability of patients surviving to six months after randomization without progression. Disease progression was evaluated by an independent review committee and by the investigators, independently. The evaluation by the independent review committee was used for the primary outcome measure. The measurement "Number" the estimated PFS-6 value from the Kaplan-Meier curve of PFS.
Secondary	Objective Tumor Response in Phase I	From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.	Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review.
Secondary	Objective Tumor Response in Phase II	From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days	Objective Tumor Response is defined as complete response (CR) and partial response (PR) according to the MacDonald criteria assessed by central independent review. Only data collected until cut-off date July 15, 2016 were considered.
Secondary	Progression-free Survival (PFS)- Phase II Part	from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.	Progression-free survival was defined as the duration between randomization and the date of the first of the two following events: progression or death.
Secondary	AUCτ,ss for Afatinib	Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1	Area under the plasma concentration-time curve of afatinib after multiple administration (AUCτ,ss) of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide (TMZ).
Secondary	Cmax,ss for Afatinib	Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1	maximum measured plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide.
Secondary	Tmax,ss for Afatinib	Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1	time from dosing to the maximum plasma concentration of afatinib after multiple administration of 50 mg afatinib in presence and absence of 75 mg/m² temozolomide
Secondary	AUC (0-8) for Temozolomide	Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1	Area under the plasma concentration-time curve over the time interval from zero to 08h (AUC (0-8)) of temozolomide in presence and absence of afatinib.
Secondary	Cmax for Temozolomide	Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1	maximum measured plasma concentration following the first dose of uniform intervals τ (Cmax) of temozolomide in presence and absence of afatinib.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With DLT- Phase I	From randomization till data cut-off (10 Jun 2009), with a mean treatment duration of 51 days		participants	NUMBER
PRIMARY	Progression-free Survival (PFS-6) at Six Months - Phase II	At six months after randomization	Randomised Set (RS). The randomised set includes all patients who were randomised to receive treatment in the Phase II part of the trial.	probablity of survival	NUMBER
SECONDARY	Objective Tumor Response in Phase I	From treatment start until the date of first documented progression or data cutoff at May 12, 2011, whichever came first, with a mean treatment duration of 69.7 days.	Patients treated in Phase I part	participants	NUMBER
SECONDARY	Objective Tumor Response in Phase II	From randomization to until the date of first documented progression or data cutoff on July 15, 2016, whichever came first, with a mean treatment duration of 110.0 days	RS	participants	NUMBER
SECONDARY	Progression-free Survival (PFS)- Phase II Part	from date of randomization until the date of first documented progression or death by any cause, whichever came first, assessed up to 9 Months.	Randomized set	Months	MEDIAN
SECONDARY	AUCτ,ss for Afatinib	Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24 h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1	PKS Set and the patients who had enough PK samples for calculation of AUC. Pharmacokinetic set (PKS) : All patients who provided at least one blood sample were included in the Pharmacokinetic (PK) analysis.	ng·h/mL	GEOMETRIC_MEAN
SECONDARY	Cmax,ss for Afatinib	Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1	PKS set	ng/mL	GEOMETRIC_MEAN
SECONDARY	Tmax,ss for Afatinib	Before (-0.05 h) the drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h and 24h after drug administration on Day 15 (in presence of temozolomide) and Day 28 (in absence of temozolomide) of treatment Cycle 1	PKS set	hour	MEDIAN
SECONDARY	AUC (0-8) for Temozolomide	Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1	PKS set	ng·h/mL	GEOMETRIC_MEAN
SECONDARY	Cmax for Temozolomide	Before (-0.05 h) the first drug administration and 0.5, 1, 1.5, 2, 3, 4, 6, 8 h after drug administration on Day 1 (in absence of afatinib) and Day 15 (in presence of afatinib) of treatment Cycle 1	PKS set	ng/mL	GEOMETRIC_MEAN

1 to 10 of 31Source ClinicalTrials.gov

See all 31 outcomes

Results by group291

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

Outcome	Group	Value	Spread	Units
Number of Participants With DLT- Phase I	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	2		participants
Number of Participants With DLT- Phase I	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	0		participants
Number of Participants With DLT- Phase I	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	4		participants
Progression-free Survival (PFS-6) at Six Months - Phase II	Phase II - Temozolomide 75mg/m^2	0.230	95% Confidence Interval 0.09 to 0.37	probablity of survival
Progression-free Survival (PFS-6) at Six Months - Phase II	Phase II - Afatinib 40mg	0.030	95% Confidence Interval 0.00 to 0.09	probablity of survival
Progression-free Survival (PFS-6) at Six Months - Phase II	Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2	0.103	95% Confidence Interval 0.00 to 0.21	probablity of survival
Objective Tumor Response in Phase I	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	0		participants
Objective Tumor Response in Phase I	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	1		participants
Objective Tumor Response in Phase I	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	0		participants
Objective Tumor Response in Phase II	Phase II - Temozolomide 75mg/m^2	4	2.9 to 24.2	participants

1 to 10 of 291Source ClinicalTrials.gov

See all 291 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	6
Overall Study	STARTED	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	8
Overall Study	STARTED	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	18
Overall Study	STARTED	Phase II - Temozolomide 75mg/m^2	39
Overall Study	STARTED	Phase II - Afatinib 40mg	41
Overall Study	STARTED	Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2	39
Overall Study	COMPLETED	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	0
Overall Study	COMPLETED	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	0
Overall Study	COMPLETED	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	0
Overall Study	COMPLETED	Phase II - Temozolomide 75mg/m^2	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,218

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	Lymphopenia	Blood and lymphatic system disorders	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	0	6
other	Lymphopenia	Blood and lymphatic system disorders	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	0	8
other	Lymphopenia	Blood and lymphatic system disorders	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	1	18
other	Lymphopenia	Blood and lymphatic system disorders	Phase II - Temozolomide 75mg/m^2	5	39
other	Lymphopenia	Blood and lymphatic system disorders	Phase II - Afatinib 40mg	0	41
other	Lymphopenia	Blood and lymphatic system disorders	Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2	0	39
other	Thrombocytopenia	Blood and lymphatic system disorders	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	1	6
other	Thrombocytopenia	Blood and lymphatic system disorders	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	0	8
other	Thrombocytopenia	Blood and lymphatic system disorders	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	0	18
other	Thrombocytopenia	Blood and lymphatic system disorders	Phase II - Temozolomide 75mg/m^2	3	39

1 to 10 of 1,218Source ClinicalTrials.gov

See all 1,218 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2
Total, all-cause mortality	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2
Total, all-cause mortality	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2
Total, all-cause mortality	Phase II - Temozolomide 75mg/m^2
Total, all-cause mortality	Phase II - Afatinib 40mg
Total, all-cause mortality	Phase II - Afatinib 40mg Plus Temozolomide 75 mg/m^2
Total, other adverse events	Phase I - Afatinib 20 mg Plus Temozolomide 75mg/m^2	6	6
Total, other adverse events	Phase I - Afatinib 40 mg Plus Temozolomide 75mg/m^2	8	8
Total, other adverse events	Phase I - Afatinib 50 mg Plus Temozolomide 75mg/m^2	18	18
Total, other adverse events	Phase II - Temozolomide 75mg/m^2	36	39

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

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 comparisons0

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

None in this release.

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/NCT00727506

GET https://conductscience.org/api/trials/v1/NCT00727506/registered?page=2

API reference For AI assistants