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Trial record 1 of 1 for:    NCT03454919
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Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations

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ClinicalTrials.gov Identifier: NCT03454919
Recruitment Status : Unknown
Verified February 2018 by Jun Guo, Beijing Cancer Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 6, 2018
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Kiang Wu Hospital
Information provided by (Responsible Party):
Jun Guo, Beijing Cancer Hospital

Brief Summary:
It is a prospective, phase II, open-labeled, clinical trial aimed to determine the efficacy of palbociclib in advanced melanoma patients who bear gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss]. Fifteen patients, if there is a response then further 45 patients will be enrolled. Totally 60 subjects with known above-mentioned gene aberrations who comply with the inclusion and exclusion criteria will be enrolled, their serum samples (at the time of the first administration of palbociclib and every 4 weeks afterwards) will be collected. Palbociclib will be given in the dose of 125 mg orally qd d1-21 every 28 days, unless disease progression or intolerance. All patients will be evaluated for the response to palbociclib by Response Evaluation Criteria in Solid Tumors (RECIST) at baseline. The standard radiographic imaging (CT scans) will be performed every 4 weeks until the end of treatment.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Palbociclib Phase 2

Detailed Description:
This study is to evaluate efficacy of palbociclib in advanced acral melanoma patients with gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss].

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study on Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations
Estimated Study Start Date : March 30, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Palbociclib
single arm
Drug: Palbociclib

Drug: palbociclib; ibrance; Pfizer Inc,New York,NY Schedule: Recommended initial dosage 125mg/d,3 weeks on, 1 week off. If grade 3 or 4 adverse events occur during treatment,dosage could be reduced to 100mg/d, even 75mg/d.

Duration: till disease progression or drug intolerance.

Other Name: ibrance




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    complete and partial response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1


Secondary Outcome Measures :
  1. PFS [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    Progression free survival

  2. 6-month PFS rate [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months ]
    6-month PFS rate

  3. AE [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months ]
    adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age from 18 to 75 years;
  2. ECOG performance status 0 or 1 before treatment;
  3. Metastatic melanoma or unresectable acral melanoma;
  4. Histologically confirmed melanoma.
  5. Bearing gene aberrations in cell cycle pathways [including CDK4 amplification and/or CCND1 amplification and/or P16 (CDKN2A) loss].;
  6. Anticipated life expectancy ≥ 3 month;
  7. Adequate organ function, defined as following criteria:

    1. Platelets 75 x 109/L, Hemoglobin 9.0 g/dL, Absolute Neutrophils(ANC) ≥ 1.5x109/L;
    2. Serum bilirubin ≤ 1.5*upper limit of normal (ULN) (could be ignored in the case of Gilbert's syndrome) ,Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 * ULN;
    3. Blood urea nitrogen (BUN) ≤ 1.5 * ULN, serum creatinine (Cr) ≤ 1.5 * ULN.
    4. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiography;
    5. QTc interval: male < 450msec, female < 470msec (via Fridericia method)
  8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  9. Written informed consent signed.

Exclusion Criteria:

  1. Previous or current administration of any kind of CDK4/6 inhibitors;
  2. Administration of any other anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, endocrinal therapy, surgery, molecular targeted therapy, immunotherapy or biological therapy) 4 weeks before inclusion; administration of mitocycin or nitrosamines 8 weeks before inclusion;
  3. Non-treated brain metastasis (treatment controlled stable brain metastasis judged by investigators excluded);
  4. Presence of third space fluid that cannot be controlled by drainage or other means (i.e. pleural effusion or ascites);
  5. Long-term steroid therapy required;
  6. Uncorrectable hypokalemia or hypomagnesaemia before inclusion;
  7. Concurrent administration of drugs with potential of QT interval prolongation (such as antiarrhythmic drugs);
  8. Allergies or previous history of severe allergies;
  9. Active HBV or HCV infection (HBV viral copy number ≥ 104 copies/ml, HCV ≥ 103 copies/ml);
  10. NCICTCAE Grade 2 toxicity before inclusion;
  11. Diagnosed as any second primary malignant tumor in 5 years before inclusion;
  12. Following conditions occur in the 6 months before drug administration: severe/ unstable angina pectoris, myocardial infarction, congestive heart failure with symptoms, cerebrovascular accident, including transient ischemic attack, pulmonary embolism, ≥ grade II renal dysfunction, and other severe diseases that investigators judged to be unsuitable for this trial;
  13. Administration of potent CYP3A4 inhibitors in 7 days before inclusion , or administration of potent CYP3A4 inhibitors in 12 days before randomization ;
  14. NCICTCAE Grade ≥ 2 Active arrhythmias;
  15. Hypertension, defined as systolic blood pressure >150mmHg and/or diastolic blood pressure >100mmHg,and cannot be controlled by medication;
  16. No recommendation to receive >2 mg Warfarin treatment in 2 weeks before study beginning. It is permitted to use low dose Warfarin(<2 mg/3day) to prevent deep venous thrombosis. Low molecular weight heparin (fractionated) or aspirin are also allowed;
  17. Existence of any disease affecting drug absorption, including but not limited to: no ability to swallow oral medications, active inflammatory bowel disease, partial or complete obstruction, partial or total gastrectomy, extensive bowel resection or chronic diarrhea;
  18. Known infection of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or congenital immune deficiency diseases, organ transplantation history;
  19. Pregnancy, breastfeeding, childbearing age female who is reluctant to take effective contraceptive measures throughout trial period. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days before randomization and at first day of every cycle on visit.
  20. Other severe acute or chronic physiological or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  21. Current treatment on another clinical trial. Supportive care or non-therapeutic clinical trials are allowed.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jun Guo, Director, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03454919    
Other Study ID Numbers: 2017-003
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action