Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Invasive Thymoma and Thymic Carcinoma, Recurrent Thymoma and Thymic Carcinoma, Stage III Thymoma, Stage IVA Thymoma, Stage IVB Thymoma

Thank you

Trial Information

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


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.


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.

Inclusion Criteria:

- Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (complete and partial response)

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Patrick Loehrer

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

June 2008

Completion Date:

November 2013

Related Keywords:

  • Invasive Thymoma and Thymic Carcinoma
  • Recurrent Thymoma and Thymic Carcinoma
  • Stage III Thymoma
  • Stage IVA Thymoma
  • Stage IVB Thymoma
  • Carcinoma
  • Thymoma



Indiana University Medical Center Indianapolis, Indiana  46202
Stanford University Hospitals and Clinics Stanford, California  94305