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Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Primary Purpose

Recurrent Melanoma, Stage IIA Melanoma, Stage IIB Melanoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

saracatinib

About this trial

This is an interventional treatment trial for Recurrent Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saracatinib

Arm Description

Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Objective Response Rate

Response will be evaluated in this study using 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. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum LD; Objective response = CR + PR. CT scans will be performed at baseline and every 4-8 weeks while on study.

Secondary Outcome Measures

Progression-free Survival

Progression will be evaluated in this study using the RECIST criteria (the appearance of new lesions and/or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study). Progression-free survival time was calculated as the time from treatment start to date of progression or death, whichever comes first.

Full Information

NCT ID

NCT00669019

First Posted

April 26, 2008

Last Updated

May 6, 2014

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00669019

Brief Title

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

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Melanoma, Stage IIA Melanoma, Stage IIB Melanoma, Stage IIC Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saracatinib

Arm Type

Experimental

Arm Description

Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

saracatinib

Other Intervention Name(s)

AZD0530

Primary Outcome Measure Information:

Title

Objective Response Rate

Description

Time Frame

Up to 25 weeks

Secondary Outcome Measure Information:

Title

Progression-free Survival

Description

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Gajewski

Organizational Affiliation

University of Chicago Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago Comprehensive Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1470

Country

United States

12. IPD Sharing Statement

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Saracatinib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

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