Mechanistic Evaluation on Sorafenib Induced Hypophosphatemia.

NCT00622479 | Terminated Phase 1

• 1 other identifier: 12345
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to:

1. 1.To elucidate the mechanism involved in the sorafenib-induced hypophosphatemia and possible early effect of hypophosphatemia on bone mineral density
2. 2.A secondary objective to assess the effect sorafenib treatment on evaluate left ventricular function (LVEF) and Beta-type natriuretic peptide in plasma.

Conditions

Carcinoma, Renal Cell

Keywords

Sorafenib; Hypophosphatemia; Left ventricular ejection fraction (LVEF); Beta-type Natriuretic Peptide (BNP)

Outcome Measures

Primary Outcomes (1)

• To evaluate a potential mechanism of hypophosphatemia related to sorafenib treatment based on measurement of phosphate regulating factors, peptides, and related laboratory variables

  Occur when the last query is resolved

Secondary Outcomes (1)

• To assess the effect of sorafenib treatment on left ventricular ejection fraction (LVEF) and B-type Natriuretic Peptide (BNP) in plasma

  Occur when the last query is resolved

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006) DRUG

Sorafenib will be administered at 400mg BID for a 28 day cycle.

Arm 1

Eligibility Criteria

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

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (7)

Unknown Facility

Scottsdale, Arizona, 85259, United States

Location

Unknown Facility

Jacksonville, Florida, 32224, United States

Location

Unknown Facility

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

Stony Brook, New York, 11794-944, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Hypophosphatemia

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 25, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (7)