Tofacitinib in Recurrent GBM Patients

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05326464
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tofacitinib 10mg — DRUG
    10 mg given orally twice daily until evidence of progression, intolerance of treatment, withdrawal of consent, or death.
  • Temozolomide — DRUG
    Temozolomide 150mg/m2 - 200mg/m2 on days 1-5
  • Lomustine — DRUG
    Lomustine 90mg/m2 on day 1

Study Details

The purpose of this study is to examine the effects of Tofacitinib in patients with recurrent Glioblastoma.

Key Dates

First listed
Apr 13, 2022
Start date
Oct 7, 2022
Status verified
Jun 2026
Primary completion
Feb 18, 2025
Completion
Oct 31, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Newly diagnosed or Recurrent off Temozolomide
    Participants will take Tofacitinib 10mg BID x 28 days with Temozolomide 150mg/m2 on days 1-5.
  • Experimental: Recurrent disease on Temozolomide
    Tofacitinib 10mg BID x 42 days Lomustine 90mg/m2

Primary Outcome Measure

Progression-free Survival (PFS) of the Study Cohort as Defined by RANO Criteria. [ Time Frame: From treatment initiation until documented radiographic or clinical progression by RANO criteria or death, whichever came first, assessed up to 2 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-

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