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A Phase 2 Study of AZD0530 in Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Recurrent Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IV Melanoma

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Trial Information

A Phase 2 Study of AZD0530 in Metastatic Melanoma


I. To determine whether the Src kinase inhibitor, AZD0530 (saracatinib), has single agent
clinical activity in patients with advanced melanoma.

II. To determine whether this drug will increase progression-free survival of these patients
from 3 months to 4.5 months.


I. To determine whether this drug may inhibit the activation of peripheral blood T cells
analyzed ex vivo.


Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease
progression or unacceptable toxicity.

After completion of study therapy, patients are followed for up to 8 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic melanoma

- Stage IV or unresectable stage III disease

- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or
as ≥ 10 mm by spiral computed tomography (CT) scan

- No known brain metastases

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS

- Life expectancy > 12 weeks

- White blood cell (WBC) ≥ 3,000/mcL

- Absolute neutrophil count (ANC) ≥ 1,500/mcL

- Platelet count ≥ 100,000/mcL

- Hemoglobin ≥ 9 g/dL

- Total bilirubin normal

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper
limit of normal

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Proteinuria ≤ 1+ by dipstick OR 24-hour urine protein ≤ 1 g

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to study until completion of
study treatment

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to AZD0530

- No QTc prolongation (defined as a QTc interval ≥ 480 msecs) or other significant
electrocardiogram (ECG) abnormalities

- No poorly controlled hypertension (e.g., systolic blood pressure [BP] of ≥ 140 mm Hg
or diastolic BP of ≥ 90 mm Hg)

- No condition (e.g., gastrointestinal tract disease resulting in an inability to take
oral medication or a requirement for IV alimentation), prior surgical procedures
affecting absorption, or active peptic ulcer disease that impairs the ability to
swallow AZD0530 tablets

- No intercurrent cardiac dysfunction including, but not limited to, any of the

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- No recent history of ischemic heart disease including myocardial infarction

- No uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements

- No other malignancy within the past 5 years, except definitively treated, localized,
nonmelanoma skin cancer or low-grade cervical neoplasm

- At least 4 weeks since prior and no more than one prior treatment regimen for
advanced disease

- No prior kinase inhibitor with activity against Src kinases for metastatic melanoma

- More than 4 weeks since prior luteinizing hormone-releasing hormone agonists

- No concurrent combination antiretroviral therapy for human immunodeficiency virus
(HIV)-positive patients

- No concurrent prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances

- Prohibited drugs should be discontinued 7 days prior to the administration of
the first dose of AZD0530 and for 7 days following discontinuation of AZD0530

- No other concurrent investigational agents or commercial therapies

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Description:

Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor response. All of the patients who met the eligibility criteria (with the possible exception of those who received no study medication) should be included in the main analysis of the response rate.

Outcome Time Frame:

At baseline and every 4-8 weeks for up to 8 weeks

Safety Issue:


Principal Investigator

Thomas Gajewski

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2006

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IIA Melanoma
  • Stage IIB Melanoma
  • Stage IIC Melanoma
  • Stage IV Melanoma
  • Melanoma



University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470