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Mechanistic Evaluation on Sorafenib Induced Hypophosphatemia.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00622479
Recruitment Status : Terminated
First Posted : February 25, 2008
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE February 13, 2008
First Posted Date  ICMJE February 25, 2008
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE May 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
To evaluate a potential mechanism of hypophosphatemia related to sorafenib treatment based on measurement of phosphate regulating factors, peptides, and related laboratory variables [ Time Frame: Occur when the last query is resolved ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
The primary objective is to evaluate a potential mechanism of hypophosphatemia related to sorafenib treatment based on measurement of phosphate regulating factors, peptides, and related laboratory variables. [ Time Frame: Occur when the last query is resolved 01-Sep-09 ]
Change History Complete list of historical versions of study NCT00622479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
To assess the effect of sorafenib treatment on left ventricular ejection fraction (LVEF) and B-type Natriuretic Peptide (BNP) in plasma [ Time Frame: Occur when the last query is resolved ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2008)
A secondary objective of the study is to assess the effect of sorafenib treatment on left ventricular ejection fraction (LVEF) and B-type Natriuretic Peptide (BNP) in plasma. [ Time Frame: Occur when the last query is resolved 01-Sep-09 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanistic Evaluation on Sorafenib Induced Hypophosphatemia.
Official Title  ICMJE Mechanistic Evaluations on Sorafenib Induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma
Brief Summary

The purpose of this study is to:

  1. To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and possible early effect of hypophosphatemia on bone mineral density
  2. A secondary objective to assess the effect sorafenib treatment on evaluate left ventricular function (LVEF) and Beta-type natriuretic peptide in plasma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE Drug: Sorafenib (Nexavar, BAY43-9006)
Sorafenib will be administered at 400mg BID for a 28 day cycle.
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)
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: January 18, 2011)
12
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2008)
50
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >/= 18 years
  • Histologically or cytologically confirmed advanced RCC
  • Evaluable disease with lesions measured by CT-scan or MRI according to modified Response Evaluation Criteria in Solid Tumors (RECIST)
  • ECOG Performance Status of 0 or 1
  • Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

    • Hemoglobin > 9.0 g/dL 1. Age greater Than 18 yrs old
    • Absolute neutrophil count (ANC) > 1,500/mm3
    • Platelet count 100,000/mm3
    • Total bilirubin <= 1.5 times the upper limit of normal
    • ALT and AST <= 2.5 x upper limit of normal (<= 5 x upper limit of normal for patients with liver involvement of their cancer)
    • Amylase and lipase < 1.5 x the upper limit of normal
    • PT-INR/PTT 1.5 x ULN (Patients who are being prophylactically anti-coagulated with an agent such as coumadin or low molecular weight heparin or therapeutically anti-coagulated with LMWH will be allowed to participate provided that they meet these criteria; in addition, these patients must be monitored at appropriate intervals throughout study)
    • Serum creatinine < 2.0 x the upper limit of normal or creatinine clearance (CrCl) 45 mL/min (CrCl = Wt (kg) (140-age)/72 Cr level, female 0.85) for patients with creatinine levels above 2.0 x ULN
    • Phosphate 2.0 mg/dl
    • LVEF >/= 40%
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment. Negative results must be available prior to study treatment
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 day period after last study drug dosing. The investigator should advise the patient how to achieve adequate contraception
  • Signed informed consent must be obtained prior to any study specific procedures

Exclusion Criteria:

  • Patients who meet the following criteria at the time of screening will be excluded:

    • History of cardiac disease: congestive heart failure >NYHA Class 2; hospitalization for CHF symptoms in the 6 months prior to study entry; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
    • Known history of HIV infection or chronic hepatitis B or C
    • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management
    • Active clinically serious infections (> Grade 2 CTCAE v3)
    • Known history or presence of metastatic brain or meningeal tumors (head CT or MRI at screening to confirm)
    • Patients with seizure disorder requiring medication (such as steroids or anti epileptics)
    • History of organ allograft
    • Patients undergoing renal dialysis
    • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry
    • Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry. Mitomycin C or nitrosureas should not be given within 6 weeks of study entry. Anticancer therapy is defined as any agent or combination of agents with clinically proven anticancer activity administered by any route with the purpose of affecting the cancer, either directly or indirectly, including palliative and therapeutic endpoints
    • Radiotherapy to target lesions within 4 weeks of start of study drug
    • Major surgery within 4 weeks of start of study
    • Serious, non-healing wound, ulcer, or bone fracture
    • Investigational drug therapy within 4 weeks of study entry
    • Prior exposure to sorafenib
    • Pregnant or breast-feeding patients
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
    • Known or suspected allergy to the investigational agent or any agent given in association with this trial
    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
    • Unable to swallow oral medications
    • Any malabsorption condition
    • Current treatment with bisphosphonates therapy or prior therapy with such agents within 12 weeks of enrollment
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 NCT00622479
Other Study ID Numbers  ICMJE 12345
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2014

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