Know Cancer

forgot password

Mechanistic Evaluations on Sorafenib Induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma

Phase 1
18 Years
Not Enrolling
Carcinoma, Renal Cell

Thank you

Trial Information

Mechanistic Evaluations on Sorafenib Induced Hypophosphatemia in Patients With Advanced Renal Cell Carcinoma

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

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

Outcome Time Frame:

Occur when the last query is resolved

Safety Issue:


Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

October 2010

Related Keywords:

  • Carcinoma, Renal Cell
  • Sorafenib
  • Hypophosphatemia
  • Left ventricular ejection fraction (LVEF)
  • Beta-type Natriuretic Peptide (BNP)
  • Carcinoma
  • Carcinoma, Renal Cell
  • Hypophosphatemia



Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Miami, Florida  33176
Albany, New York  12208
Flint, Michigan  48532
Hackensack, New Jersey  07601