XL092 for Prostate Cancer

(PRO-XL Trial)

Overseen By Susan Sharry

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Small molecule inhibitors

Disqualifiers: Brain metastases, Uncontrolled hypertension, Active infection, 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

Duration: 16 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine how well the study drug XL092 is helping to treat a participant's cancer after 16 weeks of treatment. Researchers will also look at how safe the XL092 is and how well the XL092 is working. XL092 is an oral tablet that will be taken once a day. Participants will return to clinic for regular visits for checkups and tests.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it mentions a washout period (time without taking certain medications) for prohibited medications before starting the study. Some medications, like megestrol acetate and certain anticoagulants, are allowed, but others may require approval from the Principal Investigator.

Research Team

Umang Swami, MD

Principal Investigator

Huntsman Cancer Institute

Eligibility Criteria

This trial is for individuals with metastatic castration-resistant prostate cancer. Participants will be taking an oral tablet called XL092 once a day and must return to the clinic regularly for checkups and tests.

Inclusion Criteria

Able to provide informed consent and willing to sign an approved consent form

Radiographic evidence of metastatic disease

My prostate cancer is confirmed without being a small cell type.

Exclusion Criteria

I haven't had radiation for bone metastasis or any other type within 2 weeks before starting the study treatment.

Other clinically significant disorders that would preclude safe study participation

I have not had major surgery recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug XL092, an oral tablet taken once per day on a 28-day cycle, for 16 weeks

16 weeks

Regular clinic visits for checkups and tests

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Treatment Details

Interventions

• XL092

Trial Overview The study is testing the effectiveness of XL092 in treating prostate cancer after 16 weeks of treatment. It also aims to evaluate the safety profile of this medication when taken daily as an oral tablet.

Participant Groups

Group I: Treatment: All Patients Experimental Treatment 1 Intervention

XL092 is an oral tablet that will be taken once per day on a 28 day cycle. Participants will take a 100mg dose. Dose reductions to 60mg or 40mg may apply for in cases of dose interruption due to treatment-related toxicity.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD