Trial · NCT03345095

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma

NCT03345095, Phase 3, Completed, European Organisation for Research and Treatment of Cancer - EORTC; results first posted 2024-01-31

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma. Trials, record NCT03345095. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03345095

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Trial

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

Title: A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma
NCT number: NCT03345095
Status: Completed
Phases: Phase 3
Enrollment: 749 participants, actual
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Conditions: Newly Diagnosed Glioblastoma
Interventions: Marizomib, Temozolomide, radiotherapy
First posted: 2017-11-17
Last updated: 2025-07-01
Results first posted: 2024-01-31

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From the date of randomization up to the date of death, assessed up to 49 months	Overall Survival (OS): OS is defined as the number of days from date of randomization to the date of death due to any cause. If a patient has not died, the data will be censored at the last date documented to be alive.
Secondary	Progression Free Survival (PFS)	From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months	PFS is defined as the number of days from date of randomization to the date of earliest disease progression based on Response Assessment in Neuro-Oncology criteria (by investigator) or to the date of death due to any cause, if disease progression does not occur. Patients for whom neither death nor progression have been documented were censored on the date of the last radiological assessment that the patient was progression-free. If a patient with no post-baseline radiological assessment then the data were censored at the date of randomization. Patients with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where the patient was documented to be progression free. Patients who received new anti-cancer therapy or cancer-related surgery prior to progression or death were not censored at the last assessment where the patient was documented as progression free prior to the new therapy.
Secondary	Health-related Quality of Life (HRQol)	From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.	HRQoL was assessed with the EORTC Quality of Life Questionnaire (QLQ-C30) version 3. The primary HRQol score is Physical Functioning. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. Physical functioning score is ranging 0 to 100. A large scores indicate a good physical functioning. A negative difference indicates a worsening physical functioning.
Secondary	Mini Mental State Examination (MMSE)	From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.	MMSE is a brief, standardized tool to grade patients' neurocognitive function. It is an 11-question measure that tests five areas of neurocognitive function: orientation, registration, attention and calculation, recall, and language. A large MMSE score indicates a good cognitive functioning. The maximum MMSE score is 30 which corresponds to the best neurocognitive function and minimum MMSE score is 0 the worst neurocognitive function.The patient's neurocognitive function are considered 'impaired' if MMSE is 26 or less and 'normal' if it is 27 or more. MMSE has been validated and extensively used in both clinical practice and research. It is reported at week 16 during the Temozolomide (TMZ) maintenance phase. A negative difference indicates a worsening cognitive functioning. Difference range reported in the data table is min -19 and max 10. The mean difference is reported with 95% confidence interval (CI). A CI which excludes 0 indicates a significant mean MMSE score change.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	From the date of randomization up to the date of death, assessed up to 49 months	Analysis population is Intention-to-treat population (ITT): All randomized patients will be analyzed in the arm they were allocated by randomization	Months	MEDIAN
SECONDARY	Progression Free Survival (PFS)	From the date of randomization until the date of first objective progression or the date of patient's death whichever occurs first, assessed up to 49 months	The analysis population is Intention-to-treat population (ITT): All randomized patients will be analyzed in the arm they were allocated by randomization.	Months	MEDIAN
SECONDARY	Health-related Quality of Life (HRQol)	From randomization until progression or death which ever occurs first, reported at week 16 by the mean difference from baseline assessment.	At week 16 during the TMZ maintenance phase, HRQol was obtained from 212 patients in the Experimental arm and 207 patients in the Standard arm.	score on a scale	MEAN
SECONDARY	Mini Mental State Examination (MMSE)	From the date of randomization until end of treatment. It is reported at week 16 by the mean difference from baseline assessment.	At week 16 during the TMZ maintenance phase, HRQol was obtained from 180 patients in the Experimental arm and 166 patients in the Standard arm.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Experimental Arm	16.13	95% Confidence Interval 14.92 to 17.77	Months
Overall Survival (OS)	Standard Arm	15.08	95% Confidence Interval 13.73 to 16.99	Months
Progression Free Survival (PFS)	Experimental Arm	6.34	95% Confidence Interval 5.82 to 7.85	Months
Progression Free Survival (PFS)	Standard Arm	6.11	95% Confidence Interval 4.93 to 7.29	Months
Health-related Quality of Life (HRQol)	Experimental Arm	-11.8	95% Confidence Interval -15.0 to -8.7	score on a scale
Health-related Quality of Life (HRQol)	Standard Arm	-5.4	95% Confidence Interval -8.0 to -2.9	score on a scale
Mini Mental State Examination (MMSE)	Experimental Arm	-0.95	95% Confidence Interval -1.51 to -0.38	score on a scale
Mini Mental State Examination (MMSE)	Standard Arm	-0.39	95% Confidence Interval -0.82 to 0.04	score on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental Arm	374
Overall Study	STARTED	Standard Arm	375
Overall Study	COMPLETED	Experimental Arm	125
Overall Study	COMPLETED	Standard Arm	8
Overall Study	NOT COMPLETED	Experimental Arm	249
Overall Study	NOT COMPLETED	Standard Arm	367

Source ClinicalTrials.gov

Adverse events1,590

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	Experimental Arm	16	305
other	Anaemia	Blood and lymphatic system disorders	Standard Arm	18	297
other	Febrile Neutropenia	Blood and lymphatic system disorders	Experimental Arm	0	305
other	Febrile Neutropenia	Blood and lymphatic system disorders	Standard Arm	1	297
other	Leukopenia	Blood and lymphatic system disorders	Experimental Arm	8	305
other	Leukopenia	Blood and lymphatic system disorders	Standard Arm	6	297
other	Lymphopenia	Blood and lymphatic system disorders	Experimental Arm	18	305
other	Lymphopenia	Blood and lymphatic system disorders	Standard Arm	18	297
other	Neutropenia	Blood and lymphatic system disorders	Experimental Arm	13	305
other	Neutropenia	Blood and lymphatic system disorders	Standard Arm	11	297

1 to 10 of 1,590Source ClinicalTrials.gov

See all 1,590 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Experimental Arm	55	309
Total, all-cause mortality	Standard Arm	57	307
Total, other adverse events	Experimental Arm	300	305
Total, other adverse events	Standard Arm	283	297
Total, serious adverse events	Experimental Arm	114	305
Total, serious adverse events	Standard Arm	80	297

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
Experimental Arm vs Standard Arm: deaths from any cause	Trial comparisons
Experimental Arm vs Standard Arm: 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/NCT03345095

GET https://conductscience.org/api/trials/v1/NCT03345095/events?page=2

API reference For AI assistants