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Trial record 3 of 31 for:    ACITRETIN

A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma

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ClinicalTrials.gov Identifier: NCT02050321
Recruitment Status : Terminated (Pharmaceutical company pulled support for the trial.)
First Posted : January 30, 2014
Results First Posted : April 19, 2017
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE January 24, 2014
First Posted Date  ICMJE January 30, 2014
Results First Submitted Date  ICMJE March 8, 2017
Results First Posted Date  ICMJE April 19, 2017
Last Update Posted Date December 25, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
Rate of Development of cSCC at 6 Months (Biopsy Confirmed). [ Time Frame: 6 months post treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02050321 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
Number of Participants With Adverse Events [ Time Frame: Baseline through 30 Days post Treatment ]
The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
Adverse Events [ Time Frame: Basline through 30 Days post Treatment ]
The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma
Official Title  ICMJE A Phase II Study of Vemurafenib Combined With Acitretin in Patients With Advanced Melanoma
Brief Summary We propose to conduct a phase 2 study to assess whether the addition of acitretin to vemurafenib therapy is able to decrease the rate of cutaneous squamous cell carcinoma (cSCC) development, a known side effect of vemurafenib therapy, in patients with advanced melanoma. Further, we seek a preliminary assessment as to whether the addition of acitretin to vemurafenib enhances the clinical efficacy of this anti-melanoma agent.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Melanoma
Intervention  ICMJE
  • Drug: Acitretin
    A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
    Other Name: Soriatane
  • Drug: Vemurafenib
    A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
    Other Name: Zelboraf
Study Arms  ICMJE Experimental: Acitretin and Vemurafenib
Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.
Interventions:
  • Drug: Acitretin
  • Drug: Vemurafenib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 12, 2015)
2
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2014)
37
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed advanced melanoma.
  • BRAF mutation detected by DNA sequencing of exon 15.
  • Age 18 or older.
  • ECOG Performance Status 0-2.
  • Appropriate tumor imaging studies (i.e. CT scan chest, abdomen and pelvis or PET/CT scan) performed within 28 days of study registration.
  • Patients with melanoma measurable by RECIST 1.1 criteria will be monitored using this system for evidence of disease response/progression.
  • Patients with a known history of brain metastases must have a diagnostic quality MRI of the brain or contrasted CT scan of the head performed within 28 days prior to registration.
  • Female patients of child bearing capacity must have had 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial acitretin prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue acitretin therapy. The second pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual period immediately preceding the beginning of acitretin therapy. The second test will be need to be repeated if not performed within 14 days prior to registration.
  • Willingness to use at least two forms of contraception during sexual intercourse, including at least one form of barrier contraception, for at least 30 days prior to receiving the first dose of acitretin AND during the study period, AND up to 3 years after receiving the last dose of acitretin.
  • Patients must agree not to consume alcoholic beverages while receiving acitretin and for 2 months after cessation of therapy.
  • Electrocardiogram with QTc <450 ms at baseline.
  • Patients must be evaluated for the following within 14 days prior to registration:

    • leukocytes >3,000/mcL
    • absolute neutrophil count >1,500/mcL
    • platelets >100,000/mcL
    • Hemoglobin >9.0 g/dL
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • Alkaline phosphatase <2.5 X institutional upper limit of normal
    • Total bilirubin <1.5 X institutional upper limit of normal
    • Renal function serum creatinine <1.5 mg/dL OR 1.5 x institutional normal; alternatively, creatinine clearance as assessed by 24-hour urine collection ≥60 ml/min
    • Total cholesterol < 239 mg/dL or < 6.1 mmol/L
    • LDL < 159 mg/d or < 4.1mmol/L
    • HDL > 40 mg/dL or >1.0 mmol/L
    • Serum triglycerides < 199 mg/dL or < 2.2 mmol/L
    • Potassium 3.5-5.5 mMol/L
    • Magnesium 1.7-2.6mg/dL
    • Calcium 8.5-10.6 mg/dL

Exclusion Criteria:

  • Known hypersensitivity to vemurafenib, acitretin, or vitamin A analogues.
  • Uncontrolled hypertension.
  • Serious and uncontrolled hypertriglyceridemia.
  • Uncontrolled coronary artery disease or active anginal symptoms.
  • Uncontrolled brain metastases.
  • Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low-grade prostate cancer.
  • Myocardial Infarction, Transient Ischemic Attack (TIA), Cerebrovascular Accident (CVA) or symptomatic Congestive Heart Failure (CHF) within 6 months of study registration.
  • Corrected QTc interval >450ms at baseline, history of congenital long QT syndrome, or known and uncorrectable electrolyte abnormalities.
  • History of organ or hematologic transplant.
  • Underlying defined genetic syndrome based on individual or family history predisposing to high risk of non-melanoma or melanoma skin cancer as assessed by the treating Oncologist.
  • Concurrent use of St John's Wort.
  • Concurrent (or within 60 days prior to acitretin dosing) use of methotrexate or other tetracyclines, phenytoin, vitamin A supplements, Tegison (etretinate) or progestin-only oral contraceptives.
  • Pregnant or nursing.
  • Receipt of any other investigational agents.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02050321
Other Study ID Numbers  ICMJE 1312167559
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee Cranmer, MD, PhD University of Arizona
PRS Account University of Arizona
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP