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NCT02974621

Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma

Active, enrolled Phase 2 Results posted Last updated 3 August 2025
What this trial tests

Phase 2 trial testing Bevacizumab in Recurrent Glioblastoma in 70 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
7 December 2017
Primary endpoint
31 December 2022
17 July 2026

Quick facts

Lead sponsorNational Cancer Institute (NCI)
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment70
Start date7 December 2017
Primary completion31 December 2022
Estimated completion17 July 2026
Sites27 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Progression-Free Survival at 6 Months Primary · 6 months

Progression-Free Survival (PFS) is defined as the time from randomization to progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria, or death due to any cause, whichever occurs first. Participants alive without PD are censored at date of last disease evaluation. PD criteria: (A) 25% increase in sum of the products of perpendicular diameters of enhancing lesions (over best response or baseline if no decrease) on stable or increasing doses of steroids and/or one or more of the following: (B) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasi

GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)165 – 32
Arm B (Bevacizumab)2811 – 47
Progression Free Survival Secondary · Up to 3 years

Progression free survival is defined as the time from randomization until progressive disease or death from any cause.

GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)11863 – 173
Arm B (Bevacizumab)9245 – 142
Overall Survival (OS) Secondary · up to 3 years

Overall Survival (OS) is defined as the time from randomization to death due to any cause, or censored at date last known alive.

GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)316178 – 459
Arm B (Bevacizumab)218135 – 368
Incidence of Adverse Events (AE) Secondary · Up to 3 years

The grade of adverse events be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events 5.0. The incidence of an adverse event at a particular grade is the number of patients who experienced that adverse event/grade.

Anemia
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)2
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)32
Arm B (Bevacizumab)25
Leukopenia
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)1
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)33
Arm B (Bevacizumab)25
Neutropenia
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)1
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)1
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)32
Arm B (Bevacizumab)25
Lymphopenia
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)2
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)32
Arm B (Bevacizumab)25
Thrombocytopenia
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)1
Arm A (Olaparib, Cediranib Maleate)1
Arm B (Bevacizumab)1
Arm A (Olaparib, Cediranib Maleate)33
Arm B (Bevacizumab)23
Hypertension
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)3
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)31
Arm B (Bevacizumab)25
Heart Failure
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)1
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)33
Arm B (Bevacizumab)25
Transaminitis
GroupValue95% CI
Arm A (Olaparib, Cediranib Maleate)1
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)0
Arm B (Bevacizumab)0
Arm A (Olaparib, Cediranib Maleate)33
Arm B (Bevacizumab)25

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A (Olaparib, Cediranib Maleate)
Serious: 16/34 (47%)
Deaths: 31/35
Arm B (Bevacizumab)
Serious: 13/25 (52%)
Deaths: 23/35

Serious adverse events (24 terms)

ReactionSystemArm A (Olaparib, Cediranib…Arm B (Bevacizumab)
SeizureNervous system disorders
Neoplasms - Other - Disease ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Heart FailureCardiac disorders
Death, not otherwise specifiedGeneral disorders
FeverGeneral disorders
EsophagitisGastrointestinal disorders
Neutrophil count decreasedInvestigations
White blood cell decreasedInvestigations
DehydrationMetabolism and nutrition disorders
Muscle weakness lower limbMusculoskeletal and connective tissue disorders
SomnolenceNervous system disorders
Muscle weakness right-sidedMusculoskeletal and connective tissue disorders
Muscle weakness left-sidedMusculoskeletal and connective tissue disorders
ConfusionPsychiatric disorders
Erythema multiformeSkin and subcutaneous tissue disorders
Thromboembolic eventVascular disorders
CholecystitisHepatobiliary disorders
Infections & infestations - Other - Upper Respiratory InfectionInfections and infestations
Joint infectionInfections and infestations
FallInjury, poisoning and procedural complications
Metabolism and nutrition - Other - Diabetes InsipidusMetabolism and nutrition disorders
DysphasiaNervous system disorders
Intracranial hemorrhageNervous system disorders
SyncopeNervous system disorders
Other adverse events (175 terms — click to expand)

ReactionSystemArm A (Olaparib, Cediranib…Arm B (Bevacizumab)
Urinary tract infectionInfections and infestations
HypertensionVascular disorders
DiarrheaGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
FatigueGeneral disorders
NauseaGastrointestinal disorders
ALT increasedInvestigations
Platelet count decreasedInvestigations
Gait disturbanceGeneral disorders
HeadacheNervous system disorders
VomitingGastrointestinal disorders
FallInjury, poisoning and procedural complications
HypothyroidismEndocrine disorders
ProteinuriaRenal and urinary disorders
AnemiaBlood and lymphatic system disorders
DizzinessNervous system disorders
SeizureNervous system disorders
Weight lossInvestigations
HyponatremiaMetabolism and nutrition disorders
Lymphocyte count decreasedInvestigations
Neutrophil count decreasedInvestigations
White blood cell decreasedInvestigations
ConfusionPsychiatric disorders
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
DyspepsiaGastrointestinal disorders
HematuriaRenal and urinary disorders
HypokalemiaMetabolism and nutrition disorders
Mucositis oralGastrointestinal disorders
Muscle weakness left-sidedNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
AST increasedInvestigations
Blood bilirubin increasedInvestigations
DysphagiaGastrointestinal disorders
DysphasiaNervous system disorders
Edema limbsGeneral disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
HoarsenessRespiratory, thoracic and mediastinal disorders
HyperglycemiaMetabolism and nutrition disorders
HyperkalemiaMetabolism and nutrition disorders

Most-reported serious reactions: Seizure, Neoplasms - Other - Disease Progression, Heart Failure, Death, not otherwise specified, Fever, Esophagitis, Neutrophil count decreased, White blood cell decreased.

Data from ClinicalTrials.gov NCT02974621 adverse events section.

Sponsor's own description

This randomized phase II trial studies how well cediranib maleate and olaparib work compared to bevacizumab in treating patients with glioblastoma that has come back (recurrent). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Current Challenges and Opportunities in Treating Glioblastoma.
    Shergalis A, Bankhead A, Luesakul U, Muangsin N, et al · · 2018 · cited 612× · PMID 29669750 · DOI 10.1124/pr.117.014944
  2. Glioblastoma multiforme (GBM): An overview of current therapies and mechanisms of resistance.
    Wu W, Klockow JL, Zhang M, Lafortune F, et al · · 2021 · cited 532× · PMID 34302977 · DOI 10.1016/j.phrs.2021.105780
  3. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
    Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
  4. Glioblastoma Therapy: Past, Present and Future.
    Obrador E, Moreno-Murciano P, Oriol-Caballo M, López-Blanch R, et al · · 2024 · cited 147× · PMID 38473776 · DOI 10.3390/ijms25052529
  5. Advances in the Knowledge of the Molecular Biology of Glioblastoma and Its Impact in Patient Diagnosis, Stratification, and Treatment.
    Delgado-Martín B, Medina MÁ. · · 2020 · cited 129× · PMID 32382477 · DOI 10.1002/advs.201902971
  6. Treatment options for progression or recurrence of glioblastoma: a network meta-analysis.
    McBain C, Lawrie TA, Rogozińska E, Kernohan A, et al · · 2021 · cited 105× · PMID 34559423 · DOI 10.1002/14651858.cd013579.pub2
  7. A Systematic Review of Glioblastoma-Targeted Therapies in Phases II, III, IV Clinical Trials.
    Cruz Da Silva E, Mercier MC, Etienne-Selloum N, Dontenwill M, et al · · 2021 · cited 99× · PMID 33918704 · DOI 10.3390/cancers13081795
  8. Glioblastoma under Siege: An Overview of Current Therapeutic Strategies.
    Paolillo M, Boselli C, Schinelli S. · · 2018 · cited 95× · PMID 29337870 · DOI 10.3390/brainsci8010015

Verify or expand the search:

Other trials of Bevacizumab

Trials testing the same drug.

Other recruiting trials for Recurrent Glioblastoma

Currently open trials in the same condition.

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02974621.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing