Niraparib/TTFields in GBM

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04221503
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Niraparib (\[3S\]-3-\[4-{7-(aminocarbonyl)-2H-indazol-2-yl} phenyl\] piperidine \[tosylate monohydrate salt\]) is an orally available, potent, highly selective poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) -1 and -2 inhibitor. The niraparib drug product is provided as 100-mg capsules filled with a dry blend of niraparib tosylate monohydrate, lactose monohydrate, and magnesium stearate in a hard gelatin capsule.
  • Optune — DEVICE
    Optune, which is manufactured by Novocure, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields ("TTFields") within the human body. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells.
  • Planned surgical resection — PROCEDURE
    Surgery of supratentorial glioblastoma (GBM).

Study Details

Evaluating the efficacy and safety of niraparib and Tumor-Treating Fields (TTFields) in recurrent glioblastoma (GBM).

Key Dates

Start date
Dec 30, 2019
Status verified
Jan 2026
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Cohort A is for subjects with recurrent glioblastoma who do not have clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort A will initiate and continue TTFields therapy for 5-7 days prior to starting niraparib.
  • Active Comparator: Cohort B
    Cohort B is for subjects with recurrent glioblastoma who have a clinical indication for surgical resection of the recurrent tumor. Subjects in Cohort B will receive TTFields for 5-7 days prior to planned surgical resection, undergo surgical resection, resume TTFields postoperatively, and initiate niraparib 5- 7 days after starting TTFields postoperatively.

Primary Outcome Measure

Disease control, defined as achievement of either CR, PR, or SD, as defined by modified Response Assessment in Neuro-Oncology (mRANO) criteria. [ Time Frame: When termination of the study or 5 years after removal from protocol therapy, whichever occurs first. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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