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A Phase II Study of BAY 43-9006 (NSC #724772) in Patients With Malignant Mesothelioma

Phase 2
18 Years
Not Enrolling
Epithelial Mesothelioma, Recurrent Malignant Mesothelioma, Sarcomatous Mesothelioma, Stage IA Malignant Mesothelioma, Stage IB Malignant Mesothelioma, Stage II Malignant Mesothelioma, Stage III Malignant Mesothelioma, Stage IV Malignant Mesothelioma

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Trial Information

A Phase II Study of BAY 43-9006 (NSC #724772) in Patients With Malignant Mesothelioma


I. To determine the response rate (partial response (PR) and complete response (CR)) in
patients with malignant mesothelioma treated with BAY 43-9006.


I. To determine 3-month failure free survival in patients with malignant mesothelioma
treated with BAY 43-9006.

II. To describe the median and overall survival of malignant mesothelioma patients treated
with BAY 43-9006.

III. To describe the toxicity profile of BAY 43-9006 in patients with malignant

IV. To determine whether mesotheliomas contain mutations in exons 11 and 15 of the B-raf
gene and correlate these findings with anti-tumor activity of BAY 43-9006.

V. To determine whether the amount of expression of phospho-ERK1/2, as determined by
immunohistochemistry from pre-treatment tumor specimens, correlates with anti-tumor activity
of BAY 43-9006 in patients with mesothelioma.

VI. To determine whether baseline levels and changes following BAY 43-9006 treatment in
angiogenic cytokines (VEGF and PDGF) correlate with anti-tumor activity of BAY 43-9006.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at least every 2 months for 1
year, every 4 months for 1 year, and then every 6 months for 1 year.

Inclusion Criteria:

- Histologically documented malignant mesothelioma, epithelial, sarcomatoid or mixed
type, not amenable to curative surgery; any site of origin of malignant mesothelioma,
including but not limited to: pleura, peritoneum, pericardium and tunica vaginalis is

- Pathology blocks or slides from a core surgical biopsy must be available for
evaluation of ERK 1/2 phosphorylation by immunohistochemistry and for sequencing of
B-raf exons 11 and 15

- Chemotherapy naive or no more than one pemetrexed containing chemotherapy regimen;
chemotherapy may have been pemetrexed alone or in combination with any other agent

- No prior tyrosine kinase/signal transduction/angiogenesis inhibitor therapy

- Prior intracavitary cytotoxic or sclerosing therapy (including bleomycin) are
acceptable; prior intrapleural cytotoxic chemotherapy will not be considered systemic

- >= 3 weeks since major surgery

- >= 4 weeks since completion of prior radiation therapy, as long as measurable disease
lies outside of the radiation port

- >= 4 weeks since the completion of prior pemetrexed-containing chemotherapy

- No treatment with an investigational agent currently or within the last 28 days

- No patients with known brain metastases; patients with known brain metastases should
be excluded from this clinical trial because of their poor prognosis and because they
often develop progressive neurologic dysfunction that would confound the evaluation
of neurologic and other adverse events

- Patients with pleural rind only disease must have at least one level with one rind
measurement >= 1.5 cm

- Measurable disease is defined as lesions that can be accurately measured in at least
one dimension (longest diameter to be recorded) as >= 20 mm with conventional
techniques (CT, MRI, x-ray) or as >= 10 mm with spiral CT scan

- ECOG Performance status of 0-1

- No prior history of allergic reactions attributed to compounds of similar chemical or
biologic composition to BAY 43-9006

- Non-pregnant and non-nursing because the effects of BAY 43-9006 on the fetus/infant
are unknown; in addition, women of child-bearing potential and men must agree to use
an appropriate method of birth control throughout their participation in this study;
appropriate methods of birth control include abstinence, oral contraceptives,
implantable hormonal contraceptives (Norplant), or double barrier methods (diaphragm
plus condom)

- Patients with a "currently active" second malignancy other than non melanoma skin
cancers and carcinoma in situ of the cervix are not eligible; patients are not
considered to have a "currently active" second malignancy if they have completed
therapy and are considered to have a less than 30% chance of risk of relapse

- No patients with uncontrolled intercurrent illness including but not limited to:
ongoing active infections, symptomatic congestive heart failure, unstable angina
pectoris, hypertension, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements

- No patients on therapeutic anticoagulation; prophylactic anticoagulation (i.e., low
dose warfarin) of venous or arterial access devices is allowed provided that the
requirements for INR are met

- No evidence of bleeding diathesis

- No HIV positive patients receiving combination anti-retroviral therapy; patients with
immune deficiency are at increased risk of lethal infections when treated with
marrow-suppressive therapy; therefore, HIV-positive patients receiving combination
anti-retroviral therapy are excluded from the study because of possible
pharmacokinetic interactions with BAY 43-9006

- Granulocytes >= 1,500/ul

- Platelet count >= 100,000/μl

- Total Bilirubin =< 1.5 x ULN

- AST (SGOT) =< 2.5 x ULN

- Creatinine or Creatinine Clearance =< 1.5 x ULN >= 60 ml/minute

- INR < 1.5

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (including complete and partial response)

Outcome Description:

The frequency of best response to the new treatment will be tabulated and the exact 95% binomial confidence intervals will be computed.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Pasi Janne

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Epithelial Mesothelioma
  • Recurrent Malignant Mesothelioma
  • Sarcomatous Mesothelioma
  • Stage IA Malignant Mesothelioma
  • Stage IB Malignant Mesothelioma
  • Stage II Malignant Mesothelioma
  • Stage III Malignant Mesothelioma
  • Stage IV Malignant Mesothelioma
  • Mesothelioma



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cancer and Leukemia Group B Chicago, Illinois  60606