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Phase II Trial of Zanzalitinib in Patients With Metastatic Castration Resistant Prostate Cancer

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorPedro Barata, MD, MSc

About this trial

This research study is for people with metastatic castrate-resistant prostate cancer (mCRPC). Zanzalintinib is a new drug that shows activity in mCRPC with soft tissue or visceral metastases who have progressed on prior treatment. Participants can stay in the research for up to 24 months as long as they experience clinical benefit from it. The purpose of this study is to learn if Zanzalinitib is effective in treating metastatic castrate-resistant prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically or cytologically confirmed metastatic castrate-resistant prostate cancer. Adenocarcinoma of prostate must be primary histology, but neuroendocrine features are allowed as long as <50% neuroendocrine histology. Tissue is not mandatory, but a pathologic report is required at time of participant enrollment.

Participants must have evidence of metastatic disease in soft tissue or visceral disease on conventional scans including CT and bone scans

Participants must have previously been treated with an ARPI (abiraterone, enzalutamide, apalutamide, darolutamide). Prior exposure to 1 line of taxane-based chemotherapy (docetaxel) is allowed.

Age ≥ 18 years.

Disqualifiers

Evidence of hormone-sensitive prostate cancer (HSPC).

Evidence of small cell prostate cancer.

Prior treatment with any TKI (including zanzalintinib)

Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.

Trial design

Design model

Single group

Treatments tested in this trial

  • Zanzalintinib

    Drug

    60mg zanzalinitib will be given daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicity

Treatment groups

19 Participants
are divided into 1 treatment group
Group A: ZanzalintiniibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiographic progression free survival (rPFS) at 6 months

rPFS is defined as the duration of time from start of treatment to time of progression

Time frame
6 months

Secondary outcomes

1

Prostate specific antigen (PSA) response

PSA response is defined as the rate that patients achieve PSA decline of greater than or equal to 50% (PSA50). PSA decline will be measured by determining the ratio to PSA obtained on cycle 5 day 1 to baseline PSA obtained cycle 1 day 1.

Time frame
6 months
2

Time to next systemic treatment

Time to next systemic treatment is measured in months from the day of treatment initiation on this study (cycle 1 day 1) to the first day of subsequent systemic cancer-directed therapy.

Time frame
24 months
3

Median progression free survival

Median progression free survival is determined by Prostate Cancer Clinical Trials Working Group (PCWG3) response criteria, which incorporates PSA and imaging. For PSA, PCWG3 defines PSA progression as an increase in PSA greater than 25% and \>2 ng/mL above the nadir. For imaging, RECIST version 1.1 will be used to asses the lymph nodes and solid organ disease.

Time frame
24 months
4

Overall Survival (OS)

Overall survival is defined as the time from start of treatment (cycle 1, day 1) until death from any cause (cancer-related or not)

Time frame
24 months

Other outcomes

Sponsors and contacts

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

Pedro Barata, MD, MSc

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: