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A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)

Phase 2
18 Years
Not Enrolling
Stage III Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Phase II Study of BAY 43-9006 (NSC 724772) in Unresectable Stage III and IV Melanoma (IND 69,869)


I. Determine the efficacy of sorafenib, in terms of anti-tumor effects and proportion of
clinical responses, in patients with previously untreated unresectable stage III or stage IV


I. Correlate the efficacy of this drug with the presence of mutant or wild-type BRAF gene in
tumors of these patients.

II. Determine the toxicity profile of this drug in these patients. III. Correlate serum
cryptic collagen epitopes with the extent of tumor burden, invasion, and metastasis in
patients treated with this drug.

IV. Determine the potential of serum cryptic collagen epitopes to serve as a surrogate
marker for monitoring the course of disease in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF
gene mutation in tumor sample (yes vs no).

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 annually.

PROJECTED ACCRUAL: A total of 26-74 patients (13-37 per stratum) will be accrued for this
study within 5.2-18.5 months.

Inclusion Criteria:

- Histologically or cytologically confirmed unresectable melanoma

- Stage III or IV disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by
conventional techniques OR > 10 mm by spiral CT scan

- Disease amenable to biopsy (first 13 patients in each stratum only)

- Brain metastases allowed provided the following criteria are met:

- Disease has remained radiologically stable for ≥ 6 weeks after completion of
whole-brain radiotherapy and remains stable at the time of study entry

- No mass effect present by radiology

- No requirement for steroid therapy to control symptoms of brain metastases

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- At least 3 months

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

- Platelet count ≥ 100,000/mm^3

- No evidence of bleeding diathesis

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Bilirubin ≤ 2 times ULN

- Creatinine ≤ 1.5 times ULN

- No uncontrolled hypertension

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No psychiatric illness that would preclude study compliance

- No pre-existing non-hematological dysfunction ≥ grade 2

- No ongoing or active infection

- No history of serious allergic reaction to eggs

- Able to swallow pills

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or other non-invasive carcinoma

- No other uncontrolled illness

- Not specified

- No prior systemic chemotherapy for metastatic disease

- See Disease Characteristics

- See Disease Characteristics

- No other concurrent investigational agents

- No concurrent therapeutic anticoagulation

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy

Type of Study:


Study Design:

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

Outcome Measure:

Response rate (RR) defined as is either a complete or a partial response using RECIST criteria

Outcome Description:

The overall response rate along with subgroup-specific response rates will be estimated at the end of the trial along with 95% confidence interval.

Outcome Time Frame:

56 days

Safety Issue:


Principal Investigator

Anna Pavlick

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

Related Keywords:

  • Stage III Melanoma
  • Stage IV Melanoma
  • Melanoma



Montefiore Medical Center Bronx, New York  10467-2490