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Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02905318
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Palbociclib Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients With Metastatic Castration-Resistant Prostate Cancer
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: Palbociclib
125mg orally days 1-21 every 28 day cycle
Drug: Palbociclib
125 mg orally on days 1-21 each 28 day cycle




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Effect of Palbociclib on PSA decline based on decrease in PSA test values from the baseline value [ Time Frame: 36 months ]
  2. Objective response determined by RECIST 1.1 [ Time Frame: 36 months ]
  3. Number and severity of adverse events [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  • 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.
  • Patients must be ≥18 years of age.
  • ECOG performance status 0 or 1 (Appendix I) and have a life expectancy of ≥ 6 months.
  • Previous Therapy:

Patients must have recovered from any treatment-related toxicities prior to registration (unless ≤ grade 1, irreversible, or considered by investigator as not clinically significant).

Surgery:

Prior major surgery is permitted provided that a minimum of 14 days have elapsed between any major surgery and enrollment, and that wound healing has occurred.

Radiation:

Prior external beam radiation or radium-223 is permitted provided a minimum of 28 days (4 weeks) have elapsed between the last dose and enrollment. Limited field radiation (for example less than 25% of marrow bearing bones) for palliation of bone pain is permitted < 2 weeks prior to starting study drug. Prior strontium-89 at any time is not permitted.

Systemic Therapy:

Prior systemic therapy is permitted as outlined below. Patients must have recovered from all reversible toxicity related to prior systemic therapy and have adequate washout prior to enrollmentas follows and as specified in the Sections below:

Longest of one of the following:

  • Two weeks;
  • The longer of 30 days or 5 half-lives for investigational agents;
  • Standard cycle length of standard therapies.

Hormonal Therapy: Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued at least 28 days (or 42 days for bicalutamide) prior to enrollment.

Cytotoxic Therapy: 0-1 prior regimen of cytotoxic chemotherapy in the CRPC setting is permitted. Prior treatment with docetaxel, cabazitaxel and mitoxantrone is permitted.

Immunotherapy: Patients may have received prior immune checkpoint inhibitors (anti PDL1 and anti CTL-4); vaccines and treatment with oncolytic viruses is permissible.

Other therapy:

  • Previous therapy with CDK or mTOR inhibitors is not allowed.
  • Prior treatment with other agents, such as tyrosine kinase or other targeted agents is permissible.
  • Systemic corticosteroids are permitted at a dose equivalent to <10 mg prednisone daily; topical applications (e.g. rash), inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intra-articular) are permitted.
  • Bisphosphonates / denosumab are permitted for treatment of hypercalcemia, osteoporosis and skeletal-related events.

    • Laboratory Requirements (within 7 days of enrollment):

Neutrophils ≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Hemoglobin ≥ 100 g/L Bilirubin ≤ 1.5 x ULN; if confirmed Gilbert's then bilirubin ≤ 3.0 x ULN AST and ALT ≤ 1.5 x ULN; if patient has liver metastases ≤ 5.0 x ULN Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min;

  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements
  • Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre.
  • In accordance with CCTG policy, protocol treatment is to begin within 2 working days of patient enrollment.
  • Men of childbearing potential must have agreed to use a highly effective contraceptive method during treatment and for 90 days after stopping treatment and should not father a child or donate sperm during this period.

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.
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905318


Contacts
Contact: Francisco Vera-Badillo 613-533-6430 paco@ctg.queensu.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Michael Kolinsky    780 432-8762      
Canada, British Columbia
BCCA - Vancouver Cancer Centre Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kim Chi    604 877-6000 ext 2746      
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Robyn J. Macfarlane    902 473-6106      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Som Mukherjee    905 387-9495 ext 64605      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Eric W. Winquist    519 685-8261      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Michael Ong    613 737-7700 ext 75051      
Canada, Quebec
CHUM-Centre Hospitalier de l'Universite de Montreal Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Fred Saad    514 890-8000 ext 27466      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Muhammad Salim    306 766-2691      
Saskatoon Cancer Centre Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Nayyer Iqbal    306 655-2710      
Sponsors and Collaborators
Canadian Cancer Trials Group
Pfizer
Investigators
Study Chair: Kim Chi BCCA - Vancouver Cancer Centre, BC Canada

Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT02905318     History of Changes
Other Study ID Numbers: I223
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action