Saracatinib in Treating Patients With Relapsed or Refractory Thymoma or Thymic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00718809
First received: July 18, 2008
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

This phase II trial is studying how well saracatinib works in treating patients with relapsed or refractory thymoma or thymic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth


Condition Intervention Phase
Invasive Thymoma and Thymic Carcinoma
Recurrent Thymoma and Thymic Carcinoma
Stage III Thymoma
Stage IVA Thymoma
Stage IVB Thymoma
Drug: saracatinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response rate (complete and partial response) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    A response rate of 20% or more will be taken as evidence of activity in this patient population. The objective response rate will be reported by each disease classification as well as both diseases combined.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Time from the date of registration to the first reported outcome event, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be examined in an exploratory fashion using Kaplan-Meier estimates.

  • Overall survival [ Time Frame: Time from the date of registration to last reported date of survival, assessed up to 5 years ] [ Designated as safety issue: No ]
    Will be examined in an exploratory fashion using Kaplan-Meier estimates.

  • Disease control rate defined as complete response (CR) + partial response (PR) + stable disease [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Will be examined in an exploratory fashion using Kaplan-Meier estimates.

  • Expected toxicities including skin rashes and diarrhea [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 39
Study Start Date: June 2008
Estimated Study Completion Date: November 2013
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: saracatinib
Given orally
Other Name: AZD0530

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718809

Locations
United States, California
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Investigators
Principal Investigator: Patrick Loehrer Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00718809     History of Changes
Other Study ID Numbers: NCI-2009-00297, IUCRO-0214
Study First Received: July 18, 2008
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Thymoma
Thymus Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Saracatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014