Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT02905318 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: I223
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate estimated by proportion of evaluable patients who had CR, PR or SD as their best response to treatment

  Clinical benefit is defined as one of the following: * PSA decline ≥ 50% * CR or PR (objective) * SD for ≥12 weeks (objective, without PSA progression)

  36 months

Secondary Outcomes (5)

• 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

• Overall survival

  36 months

• Number and severity of adverse events

  36 months

Study Arms (1)

Palbociclib

EXPERIMENTAL

125mg orally days 1-21 every 28 day cycle

Drug: Palbociclib

Interventions

Palbociclib DRUG

125 mg orally on days 1-21 each 28 day cycle

Palbociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Soft tissue or visceral disease progression or
• PCWG3 for bone progression (\>2 new lesions on bone scan or CT)
• Surgical/medical castration:
• Prior orchiectomy or
• LHRH agonist/antagonist and testosterone \< 50 ng/dL or \< 1.7 nmol/L. LHRH agonist/antagonist therapy must be maintained for the duration of study therapy and if previously discontinued, must be restarted and castrate level of testosterone present.

You may not qualify if:

• 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.
• Any medications or substances that are potent/strong inhibitors or inducers of CYP3A isoenzymes. All patients must have discontinued these medications at least 7 days prior to the first dose of protocol treatment (at least 14 days for herbal/dietary supplements and traditional Chinese medicines).
• Bisphosphonates / denosumab for reasons other than hypercalcemia, osteoporosis or skeletal-related events.
• Warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), factor X inhibitors or fondaparinux is allowed.
• Other anti-cancer or investigational agents (except LHRH)
• Patients with a history of non-compliance to medical regimens.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Pfizer: collaborator

Study Sites (7)

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kim Chi

  BCCA - Vancouver Cancer Centre, BC Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 19, 2016
• Study Start: July 4, 2017
• Primary Completion: April 29, 2022
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)