Health TrialsbyHealthPanel

XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Utah

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant aged ≥ 18 years

Radiographic evidence of metatstatic disease

Progression on or after prior treatment with 177Lu-PSMA-617 as determined by clinical investigator

ECOG Performance Status ≤ 2.

Disqualifiers

Prior treatment with XL092

Receipt of any type of small molecule kinase inhibitor, cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 2 weeks or at least 5 half-lives, whichever shorter before first dose of study treatment.

Radiation therapy for bone metastasis or any other radiation therapy within 2 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.

Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • XL092

    Drug

    XL092 will be supplied as a tablet that will be taken at home once a day. XL092 tablets should not be crushed or chewed. Participants should drink a minimum of 8 ounces of water with each dose of XL092. Participants will be given enough XL092 to take at home for a full cycle.

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Treatment: All PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with non-progressive disease after 16 weeks of treatment with XL092 as assessed by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1

To evaluate the disease control rate at 16 weeks in metastatic castrate-resistant prostate cancer (mCRPC) patients treated with XL092 after progression on 177Lu-PSMA-617

Time frame
16 weeks

Secondary outcomes

1

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.

To evaluate the safety and tolerability of XL092 in the study population.

Time frame
5 years
2

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0).

To evaluate the safety and tolerability of XL092 in the study population.

Time frame
5 years
3

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.

To evaluate the safety and tolerability of XL092 in the study population.

Time frame
5 years
4

Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.

To evaluate the safety and tolerability of XL092 in the study population.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

Exelixis

Collaborator

Source ClinicalTrials.gov
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