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Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas

Phase 2
18 Years
Not Enrolling

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Trial Information

Phase II Trial of BAY-9006 (NSC #724772) in Advanced Soft Tissue Sarcomas


- Determine the objective response rate (confirmed, complete, and partial) in patients
with advanced soft tissue sarcomas treated with sorafenib.

- Determine the 4-month progression-free survival rate in patients treated with this

- Determine the frequency and severity of adverse events in patients treated with this

OTHER OBJECTIVES (if funding permits):

- Correlate, preliminarily, a decrease in standard uptake variable (SUV) of target
lesions by positron-emission tomography scan at 4 weeks with response in patients
treated with this drug.

- Correlate, preliminarily, the phosphorylation status of KIT, PDGFR, VEGFR, and the
raf/mek/erk pathway with response in patients treated with this drug.

- Correlate, preliminarily, the most common B-raf kinase mutation with response in
patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology
(leiomyosarcoma vs liposarcoma vs angiosarcoma, hemangiosarcoma, or hemangiopericytoma).

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 every 8 weeks until disease
progression and then every 6 months for 2 years and annually for up to 3 years.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per stratum) will be accrued for this
study within 15-38 months.

Inclusion Criteria


- Histologically confirmed soft tissue sarcoma of 1 of the following histologies:

- Angiosarcoma, cutaneous or visceral

- Malignant hemangiosarcoma

- Malignant hemangiopericytoma

- Grade 3-4 leiomyosarcoma

- Grade 3-4 liposarcoma

- Must have evidence of unresectable residual disease, metastatic disease, or recurrent
disease by radiography

- Measurable disease by x-ray, scans, or physical examination

- Archived paraffin-embedded tumor sections available

- No known brain metastases



- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified


- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver

- Bilirubin normal (≤ 2.5 times ULN if due to liver metastases)

- PT, PTT, and INR normal


- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min


- No history of thromboembolic disease

- No uncontrolled hypertension


- Not pregnant or nursing

- Fertile patients must use effective contraception

- Able to swallow oral medication

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer in complete remission


Biologic therapy

- Not specified


- At least 28 days since prior chemotherapy (42 days for carmustine or mitomycin) and

- Prior adjuvant chemotherapy allowed

- No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy

- Not specified


- At least 28 days since prior radiotherapy and recovered

- Must have evidence of disease progression within, or measurable disease outside
of, the radiation field after completion of radiotherapy


- At least 28 days since prior major surgery and recovered


- No prior sorafenib

- No prior inhibitor of VEGFR or MAPK pathway

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No concurrent therapeutic anticoagulation

- No concurrent administration of any of the following medications:

- Rifampin

- Hypericum perforatum (St. John's wort)

- Cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the

- Phenytoin

- Carbamazepine

- Phenobarbital

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response (Confirmed, Complete and Partial)

Outcome Description:

Partial response (PR) is greater than or equal to 30% decrease under baseline of sum of longest diameters of all target measurable lesions; No unequivocal progression of non-measurable disease; No new lesions. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration. Stable disease does not qualify for CR, PR, Progression or Symptomatic Deterioration. Progressive disease is any one or more of the following: 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed; unequivocal progression of non-measurable disease; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Assessment inadequate is progression or symptomatic deterioration has not been documented, and one or more target measurable lesions have not been assessed or inconsistent assessment methods were used.

Outcome Time Frame:

Assessment performed every eight weeks until progression.

Safety Issue:


Principal Investigator

Margaret von Mehren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2006

Completion Date:

September 2012

Related Keywords:

  • Sarcoma
  • adult angiosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult malignant hemangiopericytoma
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma



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