Niraparib and Temozolomide in Patients Glioblastoma

Sponsor
Armando Santoro, MD
Study ID
NCT06258018
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Glioma, Malignant

Eligibility Criteria

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

Interventions

  • Temodal — DRUG
    given orally for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days
  • Niraparib — DRUG
    given orally in continous

Study Details

The study evaluates safety, tolerability, pharmacokinetics at recommended phase II dose (RP2D) and preliminary antitumor activity of Niraparib + dd-TMZ "one week on, one week off" in patients affected by recurrent GBM IDH wild-type and recurrent IDH mutant (WHO grade 2-4) gliomas. The treatment will be administered until progressive disease, unacceptable toxicity, consent withdrawal, lost to follow-up or death. The entire study is expected to last approximately 40 months.

Key Dates

Start date
Sep 30, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
86 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib + Temodal Level 0
    Niraparib 100 mg/die + TMZ 75 mg/m2 both given for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days (starting dose).
  • Experimental: Niraparib + Temodal Level 1
    Niraparib 100 mg/die + TMZ 100 mg/m2 both given for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days.
  • Experimental: Niraparib + Temodal Level 2
    Niraparib 200 mg/die + TMZ 75 mg/m2 both given for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days
  • Experimental: Niraparib + Temodal Level 3
    Level 3: Niraparib 200 mg/die + TMZ 100 mg/m2 both given for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days.
  • Experimental: Niraparib + Temodal Level -1
    Niraparib 100 mg given on alternate days for 7 days, followed by 7 days of OFF + TMZ given 75 mg/m2 for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days.
  • Experimental: Niraparib + Temodal Expansion Phase
    Niraparib RP2D dose given on alternate days for 7 days, followed by 7 days of OFF + TMZ given RP2D for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days.

Primary Outcome Measure

Escalation Phase : maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Central Contacts

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