Clinical trial NCT00669019: Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Official title: A Phase 2 Study of AZD0530 in Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Melanoma
Stage IIA Melanoma
Stage IIB Melanoma
Stage IIC Melanoma
Stage IV Melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-04-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase II trial is studying how well saracatinib works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description: PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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

OUTLINE:

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

Eligibility criteria: 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 60-100%
* 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 following:

  * 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to 25 weeks
Secondary outcomes:
measure: Progression-free Survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Thomas Gajewski
role: PRINCIPAL_INVESTIGATOR
References: