NCT02905318
Active, not recruiting
Phase 2
A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients With Metastatic Castration-Resistant Prostate Cancer
Canadian Cancer Trials Group7 sites in 1 country19 target enrollmentStarted: July 4, 2017Last updated:
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Canadian Cancer Trials Group
- Enrollment
- 19
- Locations
- 7
- Primary Endpoint
- Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment
Overview
Brief Summary
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.
Detailed Description
The standard or usual treatment for this disease may be chemotherapy or other types of treatment to slow the spread of the disease and relieve some symptoms of cancer.
Palbociclib is a new type of drug for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. Palbociclib has been shown to help patients with breast cancer but it is not known if the drug is useful for treating prostate cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have histologically confirmed adenocarcinoma of the prostate without evidence of small cell/neuroendocrine differentiation.
- •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)
- •Patients must have clinically and/or radiologically documented disease. Patients with elevated PSA only are not eligible. All radiology studies must be performed within 28 days prior to enrollment (within 35 days if negative).
- •All patients must have consented to the release of a tumour block from their primary or metastatic tumour. The centre/pathologist must have agreed to the submission of the specimen.
- •Patients must have evidence of either biochemical or radiological disease progression in the setting of surgical or medical castration:
- •PSA progression:
- •Minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement
- •PSA must be ≥2.0 ug/L
- •Objective progression:
- •RECIST 1.1 or
Exclusion Criteria
- •Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- •Patients with central nervous system (CNS) involvement unless at least 4 weeks from prior therapy completion (including radiation and/or surgery) AND clinically stable and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.
- •Patients with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the patient to be managed according to the protocol. This includes but is not limited to:
- •active infection requiring systemic therapy;
- •uncontrolled/severe cardiovascular disease
- •active or known human immunodeficiency virus (HIV);
- •Patients who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- •Patients with history of hypersensitivity to palbociclib or any of its excipients.
- •Patients who have been treated with prior CDK4/6 inhibitors, mTOR inhibitors or strontium-89 at any time or require continued or concurrent treatment with:
- •Systemic corticosteroids at a dose equivalent to prednisone \> 10 mg daily. Topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are allowed.
Arms & Interventions
Palbociclib
Experimental
125mg orally days 1-21 every 28 day cycle
Intervention: Palbociclib (Drug)
Outcomes
Primary Outcomes
Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment
Time Frame: 36 months
Clinical benefit is defined as one of the following: * PSA decline ≥ 50% * CR or PR (objective) * SD for ≥12 weeks (objective, without PSA progression)
Secondary Outcomes
- Overall survival(36 months)
- Number and severity of adverse events(36 months)
- Effect of Palbociclib on PSA decline based on decrease in PSA test values from the baseline value(36 months)
- Objective response determined by RECIST 1.1(36 months)
- Progression-free survival(36 months)
Investigators
Study Sites (7)
Loading locations...
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