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A Phase 2 Study of AZD0530 in Patients With Advanced, Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Combination Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

A Phase 2 Study of AZD0530 in Patients With Advanced, Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Combination Chemotherapy


I. Assess the rate of disease control (i.e., lack of disease progression, objective complete
and partial response, and stable disease) in patients with recurrent, stage IIIB or IV
non-small cell lung cancer treated with AZD0530 (saracatinib).


I. Assess the objective response rate (complete and partial response), stable disease rate,
and duration of response or stable disease in patients treated with AZD0530.

II. Assess the progression-free, median, and 6-month overall survival rates in patients
treated with AZD0530.

III. Assess the safety and tolerability of AZD0530 in these patients. IV. 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: This is a multicenter study.

Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every
28 days in the absence of unacceptable toxicity or disease progression.

Tumor tissue samples are collected at baseline and at 2 weeks after beginning treatment and
are analyzed for c-Src protein expression and activity by immunofluorescence staining.
P-glycoprotein levels and phosphorylation of focal adhesion kinase (FAK), paxillin,
caveolin, and Stat-3 are also measured using tumor tissue samples. Blood samples are also
used to measure levels of VEGF by ELISA.

After completion of study treatment, patients are followed every 4 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed non-small cell lung cancer, meeting both of
the following criteria:

- Locally advanced or metastatic (stage IIIB or IV) disease

- Recurrent, unresectable disease

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional
techniques or as ≥ 10 mm with spiral CT scan

- Previously treated with first-line platinum-based systemic chemotherapy for advanced
disease AND had at least stabilization of disease as best response to first-line

- No more than one line of prior therapy

- Previously treated brain metastases allowed provided they are clinically and
radiologically stable and there are no neurological symptoms or requirement for

- 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 (transfusion allowed)

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)

- Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min

- Urine protein creatinine ratio ≤ 1.0 OR urine protein < 1,000 mg by 24-hour urine

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to, during, and for 8 weeks
after completion of study treatment

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to AZD0530

- No QTc prolongation (i.e., QTc interval ≥ 460 msec) or other significant ECG

- No cardiac dysfunction including, but not limited to, the following:

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- History of ischemic heart disease, including myocardial infarction

- No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or
diastolic BP ≥ 90 mm Hg)

- No condition that would impair the ability to swallow AZD0530 tablets (e.g.,
gastrointestinal tract disease resulting in an inability to take oral medication,
requirement for IV alimentation, or active peptic ulcer disease)

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situation that would limit compliance with
study requirements

- No concurrent combination antiretroviral therapy for HIV-positive patients

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
radiotherapy, or surgery and recovered

- Prior radiotherapy to target lesions allowed provided there is disease progression

- No prior radiotherapy to > 40% of bone marrow

- No prior EGFR tyrosine kinase inhibitors

- No prior surgical procedures affecting absorption

- No CYP3A4-active agents or substances for 7 days prior to, during, and for 7 days
after completion of study treatment, including any of the following:

- Ketoconazole

- Itraconazole

- Ritonavir

- Mibefradil

- Clarithromycin

- Saquinavir

- Indinavir

- Erythromycin

- Nefazadone

- Fluconazole

- Diltiazem

- Alfentanil

- Carbamazepine

- Cyclosporine

- Tacrolimus

- Lovastatin

- Simvastatin

- No other concurrent investigational agents

- No other concurrent anticancer therapy

Type of Study:


Study Design:

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

Outcome Measure:

Rate of disease control (freedom from disease progression)

Outcome 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 possible.

Outcome Time Frame:

112 days

Safety Issue:


Principal Investigator

Scott Laurie

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Recurrent Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms