Know Cancer

forgot password

An Open-label, Non-comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma

Phase 3
18 Years
Not Enrolling
Renal Cell Carcinoma

Thank you

Trial Information

An Open-label, Non-comparative, Treatment Protocol for the Use of BAY 43-9006 (Sorafenib) in Patients With Advanced Renal Cell Carcinoma

Renal cell carcinoma (RCC) accounts for approximately 3 % of all cancers. RCC can be cured
if diagnosed and treated when still localized to the kidney or immediate surrounding
tissues. Since most of the RCC tumours are diagnosed when still localized, approximately
40 % of all patients survive 5 years. The median survival of Stage IV RCC after diagnosis is
8 to 12 months and the 5-year survival is less than 10 %. Surgery has been the primary
therapy for RCC for more than a century. Until recently, metastatic disease has been
refractory to any systemic therapy. Despite recent advances in immunotherapy (e.g.
Interferon and Interleukin-2), the response rates remain low (15 %) and few patients
experience durable remission. Surgical and radiation therapies for Stage IV disease are
generally limited to palliation of symptoms. For the majority of patients, metastatic RCC is
incurable and patients should be considered candidates for clinical trials when appropriate.
In summary, the available therapies for advanced unresectable and/or metastatic RCC have
limited clinical values, with response rates ranging from 6-20 % and little impact on the
natural history of the disease. Furthermore, the toxicities associated with these agents can
be severe, requiring careful patient selection, and this dramatically decreases the number
of patients who may benefit from therapy. Advanced RCC remains incurable and the need for
more effective therapies is high.

This is a non-randomized, open-label treatment protocol for patients with advanced RCC.
Patients will be treated with 400 mg oral sorafenib twice a day on a continuous. Patients in
this protocol may continue to be treated with sorafenib as a single agent until any of the
following criteria for drug or protocol discontinuation is reached:

1. Progression of disease.

2. The patient is unlikely to benefit from further treatment with sorafenib as judged by
the Investigator.

3. Intolerable toxicity of the drug.

4. Withdrawal of consent for any reason.

Inclusion Criteria:

1. Written informed consent prior to receiving sorafenib.

2. At least 18 years of age.

3. Advanced Renal Cell Carcinoma.

4. A patient who has received prior systemic and local therapies, must have completely
recovered from acute toxicity (i.e. resolved back to CTC-AE Grade 1 or less).

5. For patients, who have had major surgery or injury, the wound must be completely
healed prior to receiving sorafenib treatment (4 weeks).

6. Women of childbearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation. Men must use
adequate birth control for at least 3 months after the last administration of
sorafenib. Should a woman become pregnant while participating or while the partner of
a patient is participating in the study, they should inform their treating physician

Exclusion Criteria:

1. Pregnant or breastfeeding women.

2. Patients with metastatic brain or meningeal tumours.

3. Cardiac disease: greater than NYHA functional class II; unstable CAD; MI within the
last 6 months.

4. HIV infection or chronic hepatitis B or C; patients with Child-Pugh class C hepatic

5. Patients with severe renal impairment (calculated creatinine clearance of < 30
ml/min) or who require dialysis.

6. Patients with active uncontrolled hypertension.

7. Patients with recent or active bleeding diathesis.

8. Patients with any medical condition which could jeopardize their safety while taking
an investigational drug.

9. Excluded therapies or medications, previous and concomitant:

- Bone marrow transplant or stem cell rescue within 4 months of study entry.

- Anticipation of the need for major surgery during the course of the study.

- CYP 3A4 inducers (e.g. rifampicin, St. John's Wort [Hypericum perforatum],
phenytoin, phenobarbital and dexamethasone).

10. Any investigational therapy while on this protocol or within 30 days prior to their
first dose of sorafenib.

- Any drugs (licensed or investigational) that targets angiogenesis, especially
VEGF or VEGF-Receptors (e.g. bevacizumab).

- Any drug (licensed or investigational) that targets Ras-pathway or EGFR.

- Biological response modifiers, such as G-CSF or GM-CSF, within 3 weeks prior to
study entry or during study (G-CSF and other hematopoietic growth factors may
only be used in the management of acute toxicity such as febrile neutropenia,
when medically indicated or at the discretion of the Investigator).

- Use of Megestrol-acetate and medroxyprogesterone.

- Patients taking narrow therapeutic index medications will be monitored closely.

- These include warfarin, phenytoin, quinidine, carbamazepine, phenobarbital,
cyclosporine and digoxin.

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the efficacy (time to progression and progression free survival) of sorafenib in patients with advanced RCC

Outcome Time Frame:

two years

Safety Issue:


Principal Investigator

Vichien Srimuninnimit, Ass.Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Siriraj Hospital, Bangkok, Thailand


Thailand: Food and Drug Administration

Study ID:




Start Date:

May 2007

Completion Date:

March 2010

Related Keywords:

  • Renal Cell Carcinoma
  • Renal Cell Carcinoma
  • Sorafenib
  • Carcinoma
  • Carcinoma, Renal Cell