- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718809
Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer
Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the objective response rate (complete response and partial response) in patients with relapsed or refractory thymoma or thymic carcinoma treated with AZD0530.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of AZD0530 in these patients. II. To evaluate the progression-free survival of these patients. III. To evaluate the overall survival of these patients. IV. To evaluate the disease control rate, defined as complete response, partial response, and stable disease, in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral saracatinib once 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 periodically for 5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University Hospitals and Clinics
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following criteria:
- Relapsed or refractory disease
- Metastatic, unresectable disease
- Locally invasive disease allowed provided it is not resectable and has been previously treated
- Progressive disease
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
- Must have received >= 1 prior chemotherapy regimen
- No active brain metastases
- Patients with previously treated brain metastases (surgical resection or radiotherapy) are eligible provided they have documented stable brain disease for >= 1 month after completion of therapy and are asymptomatic
- ECOG performance status 0-2
- Leukocytes >= 3,000/mm^3
- ANC >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hemoglobin > 9 g/dL
- Serum bilirubin < 2.0 times upper limit of normal (ULN)
- Transaminases =< 2.5 times ULN (< 5.0 times ULN if liver metastasis is present)
- Serum creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min
- Urine protein:creatinine ratio < 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
- QTc < 460 msec
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 30 days after completion of study treatment
- No known history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
- No other malignancies within the past 3 years, except curatively treated in situ carcinoma of the cervix or completely resected nonmelanoma skin cancer
- No concurrent active malignancies other than thymic malignancy
- No condition that impairs the ability to swallow AZD0350 tablets (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)
No cardiac dysfunction including, but not limited to, any of the following:
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- History of ischemic heart disease
- Myocardial infarction within the past year
- No QTc prolongation or other significant ECG abnormalities
- No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or diastolic BP ≥ 95 mm Hg)
No evidence of severe or uncontrolled systemic conditions that would make it undesirable to participate in the study or that would jeopardize compliance with the study, including any of the following:
- Severe hepatic impairment
- Interstitial lung disease (bilateral, diffuse, or parenchymal lung disease)
- Unstable or uncompensated respiratory condition
- Unstable or uncompensated cardiac condition
No uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Mental health issues or social circumstances that would limit compliance with study requirements
- No prior src inhibitors
- At least 4 weeks since prior systemic therapy (6 weeks for carmustine or mitomycin C)
- At least 8 weeks since prior immunotherapy
- At least 4 weeks since prior octreotide
- Concurrent octreotide for pure red cell aplasia allowed provided patient continues on the same dose and schedule, has had a response to this drug, and has demonstrated progressive thymoma by radiography or physical exam
- At least 4 weeks since prior surgery and recovered
- At least 4 weeks since prior investigational agents
- At least 4 weeks since prior radiotherapy to measurable disease sites (2 weeks for palliative radiotherapy to metastatic sites) and recovered
- At least 7 days since prior and no concurrent active CYP3A4 agents or substances
- No other concurrent investigational or anticancer agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- Concurrent steroids allowed for treatment of a pre-existing autoimmune disorder or as antiemetic therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Patients receive oral saracatinib once daily on days 1-28.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Given orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (Complete and Partial Response)
Time Frame: Up to 5 years
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Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The objective response rate will be reported by each disease classification.
The percent of patients having an objective response (complete or partial response) will be estimated with a 95% exact binomial confidence interval for the percent of patients receiving drug.
Note: there were no objective responses in this trial.
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Up to 5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival
Time Frame: Time from the date of registration to the first reported outcome event, assessed up to 5 years
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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 a non-target lesion, or the appearance of new lesions.
This will be examined in an exploratory fashion using Kaplan-Meier estimates.
Time until progression, death or last evaluation will be calculated.
If a patient did not progress or die, they will be censored at their last evaluation in the analysis.
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Time from the date of registration to the first reported outcome event, assessed up to 5 years
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Overall Survival
Time Frame: Time from the date of registration to last reported date of survival, assessed up to 5 years
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Will be examined in an exploratory fashion using Kaplan-Meier estimates.
Time until death or last evaluation will be calculated.
If a patient did not die, they will be censored in the analysis.
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Time from the date of registration to last reported date of survival, assessed up to 5 years
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Disease Control Rate
Time Frame: Up to 5 years
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Will be examined in an exploratory fashion using Kaplan-Meier estimates.
Disease control rate defined as complete response (CR) + partial response (PR) + stable disease (SD).
The length of time until progression or until last evaluation will be calculated.
For patients who did not progress, they will be censored in the analysis.
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Up to 5 years
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Expected Toxicities Including Skin Rashes and Diarrhea
Time Frame: Up to 5 years
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Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.
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Up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick Loehrer, Indiana University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2009-00297
- IUCRO-0214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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