Palbociclib for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out what effects a new drug, palbociclib, has on prostate cancer and will look at the side effects of treatment with palbociclib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by palbociclib and to see how the cancer cells respond to palbociclib.

Research Team

Kim Chi

Principal Investigator

BCCA - Vancouver Cancer Centre, BC Canada

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They need rising PSA levels, ongoing hormone treatment, and no small cell/neuroendocrine differentiation in their cancer. Major organs must function well, they should have a life expectancy of at least 6 months, and agree to use effective contraception.

Inclusion Criteria

Patients must consent to blood collection for testing prior to enrollment by a central reference laboratory. Screening will be done through the CRPC Master Screening Protocol (IND234)

This criterion seems incomplete. Please provide more details.

I am mostly active and my doctor expects me to live 6 months or more.

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Exclusion Criteria

I am allergic to palbociclib or its ingredients.

I do not have an infection that needs treatment with medication.

I do not have severe heart problems.

See 12 more

Treatment Details

Interventions

Palbociclib (CDK4/6 Inhibitor)

Trial OverviewThe trial is testing palbociclib's effects on metastatic castration-resistant prostate cancer. It will assess how the drug impacts the disease and examine side effects while also looking for markers predicting who might benefit most from this treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PalbociclibExperimental Treatment1 Intervention

125mg orally days 1-21 every 28 day cycle

Palbociclib is already approved in Canada, Japan for the following indications: