Expired Study
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Dalton, Georgia 30720


Purpose:

This phase II trial is studying how well saracatinib works in treating patients with locally advanced or metastatic stomach or gastroesophageal junction cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


Study summary:

PRIMARY OBJECTIVES: I. To assess the objective disease control rate (i.e., partial or complete response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or stable disease for ≥ 16 weeks) in patients with locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with AZD0530 (saracatinib). SECONDARY OBJECTIVES: I. To assess the median time to disease progression, median overall survival, and 1-year survival rate in these patients. II. To assess the toxicity of AZD0530 in these patients. III. To evaluate potential predictive markers by assessing pretreatment intratumoral levels of src, Y419 phospho-src (P-Src), and c-terminal src kinase (Csk) in archival tumor biopsies. OUTLINE: Patients receive saracatinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at least every 2 months.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ) - Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert classification - Metastatic or locally advanced disease - Patients with local/regional disease only, must have unresectable 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 > 3 months - Platelet count ≥ 100,000/mm³ - Leukocytes ≥ 3,000/mm³ - Absolute neutrophil count ≥ 1,500/mm³ - Hemoglobin > 9 g/dL - Total bilirubin normal - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal - Creatinine normal OR creatinine clearance ≥ 60 mL/min - Urine protein creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine collection Exclusion Criteria: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No condition that potentially impairs the ability to swallow or absorb AZD0530, including any of the following: - Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation - Active peptic ulcer disease - Short gut syndrome - Malabsorption syndrome of any type - Total or partial bowel obstruction - Inability to tolerate oral medications - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530 - No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant electrocardiogram (ECG) abnormalities - No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg) - No history of ischemic heart disease, including myocardial infarction - No concurrent cardiac dysfunction including, but not limited to, any of the following: - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - No other concurrent uncontrolled illness, including ongoing or active infection or psychiatric illness/social situations, that would limit compliance with study requirements - Prior chemotherapy allowed provided it was administered as part of initial curative intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with radiotherapy) in combination with surgery - At least 4 weeks since prior chemotherapy - At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for advanced disease - At least 4 weeks since prior radiotherapy and recovered - At least 4 weeks since prior major surgery and recovered - No cytochrome 450 3A4 (CYP3A4) active agents or substances for ≥ 7 days before, during, and for ≥ 7 days after completion of study treatment - No other concurrent investigational agents - No other concurrent anticancer therapy - No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients


Study is Available At:


Original ID:

NCI-2009-00188


NCT ID:

NCT00607594


Secondary ID:

PHL-052


Study Acronym:


Brief Title:

Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer


Official Title:

A Phase 2 Study of AZD0530 in Patients With Metastatic or Locally Advanced Gastric Carcinoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

21


Enrollment Type:

Actual


Overall Contact Information

Official Name:Heather-Jane Au
Principal Investigator
University Health Network-Princess Margaret Hospital

Study Dates

Start Date:January 2008
Completion Date:April 2012
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 26, 2018
First Received Date:February 1, 2008
First Results Date:June 19, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)
Time Frame:Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up t
Safety Issues:False
Description:PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.
Outcome Type:Primary Outcome
Measure:Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)
Time Frame:Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up t
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Time to Progression
Time Frame:Up to 1 year (median, 6 month, 1-year)
Safety Issues:False
Description:Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in non-target lesions, or the appearance of new lesions.
Outcome Type:Secondary Outcome
Measure:Progression-free Survival
Time Frame:Measured from the date of enrollment to progression, death or last contact, or last tumor assessment
Safety Issues:False
Description:Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where
Outcome Type:Secondary Outcome
Measure:Median Survival
Time Frame:Up to 1 year
Safety Issues:False
Description:Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where
Outcome Type:Secondary Outcome
Measure:Overall Survival
Time Frame:Up to 1 year (median, 6 months, and 1 year)
Safety Issues:False
Description:The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interes
Outcome Type:Secondary Outcome
Measure:Highest Grade Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.
Time Frame:Weekly during treatment
Safety Issues:False
Description:Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.
Outcome Type:Secondary Outcome
Measure:Patient Tolerability
Time Frame:Weekly during treatment
Safety Issues:False
Description:Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where
Outcome Type:Secondary Outcome
Measure:Association Between Correlative Markers and Clinical Outcomes
Time Frame:At baseline, 6 months, and then at 1 year
Safety Issues:False
Description:Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where

Study Interventions

Intervention Type:Drug
Name:saracatinib
Description:Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity.
Arm Name:Treatment (kinase inhibitor therapy)
Other Name:AZD0530

Study Arms

Study Arm Type:Experimental
Arm Name:Treatment (kinase inhibitor therapy)
Description:Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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