Ruxolitinib + Standard Treatment for Brain Cancer

Overseen By Manmeet Ahluwalia, M.D., MBA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Baptist Health South Florida

Must not be taking: Warfarin

Disqualifiers: Pregnancy, Active infections, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

190 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to test the safety and effectiveness of the investigational drug ruxolitinib when it is combined with standard of care treatment (radiation therapy and temozolomide) for the treatment of newly diagnosed glioblastoma. Half the people in the study will be assigned to take the study drug ruxolitinib in addition to the standard of care temozolomide and radiation therapy and the other half will be assigned to the standard of care temozolomide and radiation therapy only. This assignment will be randomized in a 1-to-1 ratio, like the flip of a coin.

Research Team

Manmeet Ahluwalia, M.D., MBA

Principal Investigator

Miami Cancer Institute at Baptist Health, Inc.

Eligibility Criteria

This trial is for individuals newly diagnosed with glioblastoma, a type of brain cancer. Participants should not have received prior treatments for this condition. Specific eligibility criteria are not provided, but typically include factors like age, overall health status, and the stage of the tumor.

Inclusion Criteria

Provision of signed informed consent form

My liver, kidneys, and bone marrow are functioning well.

I can take care of myself but sometimes need help.

Exclusion Criteria

I am not pregnant or breast-feeding.

Any other serious medical/psychiatric condition, in the judgement of the investigator, that likely to interfere or limit compliance with study requirements/treatment

I have taken ruxolitinib before or am allergic to the study drug.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Temozolomide

Participants receive radiation therapy and temozolomide, with or without ruxolitinib, during this phase

6 weeks

Maintenance

Participants continue with temozolomide, with or without ruxolitinib, after radiation therapy is complete

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

• Radiation Therapy
• Ruxolitinib
• Temozolomide

Trial Overview The study is testing the safety and effectiveness of ruxolitinib combined with standard care (radiation therapy and temozolomide) versus standard care alone in treating glioblastoma. Participants will be randomly assigned to one of these two groups in equal numbers.

Participant Groups

Group I: Ruxolitinib plus Radiation and Temozolomide Experimental Treatment 3 Interventions

There will be two phases of drug administration: (1) Ruxolitinib and temozolomide will be administered "During Radiation Therapy" and (2) Maintenance phase after radiation therapy is complete.

Group II: Radiation and Temozolomide Active Control 2 Interventions

There will be two phases of drug administration: (1) Temozolomide will be administered "During Radiation Therapy" and (2) Maintenance phase after radiation therapy is complete.

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School