AzTrials
AzTrials

Invasive Thymoma and Thymic CarcinomaPhase 2NCT00718809

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

A Phase 2 study testing saracatinib in people with Invasive Thymoma and Thymic Carcinoma and Recurrent Thymoma and Thymic Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
saracatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesUnited States
Study dates
Jun 2008to Oct 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 54Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202

  • Stanford University Hospitals and Clinics

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase II Trial of AZD0530 for Patients With Relapsed/Refractory Thymic Malignancies (Thymoma and Thymic Carcinoma)

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
saracatinib
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saracatinibDrug

    Also called AZD0530

    Given orally

Study groups in NCT00718809
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral saracatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: saracatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (Complete and Partial Response)

    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.

    Measured: Up to 5 years

Secondary outcomes (4)

  1. Progression-free Survival

    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.

    Measured: Time from the date of registration to the first reported outcome event, assessed up to 5 years

  2. Overall Survival

    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.

    Measured: Time from the date of registration to last reported date of survival, assessed up to 5 years

  3. Disease Control Rate

    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.

    Measured: Up to 5 years

  4. Expected Toxicities Including Skin Rashes and Diarrhea

    Number of patients who had toxicities classified as skin rashes and diarrhea within the adverse events.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionAug 2010
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718809
Sponsor's protocol ID
NCI-2009-00297
Other IDs
IUCRO-0214
Status last verified
Oct 2014
First submitted
18 Jul 2008
Last updated
10 Jun 2015

Publications

  • Gubens MA, Burns M, Perkins SM, Pedro-Salcedo MS, Althouse SK, Loehrer PJ, Wakelee HA. A phase II study of saracatinib (AZD0530), a Src inhibitor, administered orally daily to patients with advanced thymic malignancies. Lung Cancer. 2015 Jul;89(1):57-60. doi: 10.1016/j.lungcan.2015.04.008. Epub 2015 Apr 25.

    PubMed 26009269

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing saracatinib in people with Invasive Thymoma and Thymic Carcinoma and Recurrent Thymoma and Thymic Carcinoma, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 54 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (Complete and Partial Response) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718809, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in