AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer

Study summary

AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedsaracatinib

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 7, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
Interventions being studied: Drug: saracatinib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Disease setting

Recurrent or relapsed→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Histologically or cytologically confirmed small cell lung cancer
No mixed histology
Extensive stage disease, defined as any of the following:
Metastatic disease outside the chest
Contralateral supraclavicular nodes or contralateral hilar nodes that cannot be included in a single radiation port
Cytologically confirmed malignant pleural effusion
Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
Previously untreated disease\
OR stable disease, partial response, or complete response ≤ 4 weeks after completion of one course (four 3-week courses) of standard platinum-based chemotherapy
No symptomatic, untreated, or uncontrolled CNS metastases
CNS metastases previously treated with whole brain radiotherapy allowed
ECOG performance status (PS) 0-2
Life expectancy ≥ 12 weeks
WBC ≥ 3,000/mm³
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin \> 9.0 g/dL
Total bilirubin \< 1.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN
ALT and AST ≤ 3 times ULN (≤ 5 times ULN if liver involvement)
Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
Proteinuria ≤ +1 on two consecutive dipsticks taken no less than 24hours apart
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective protection during and for up to 8 weeks after completion of study therapy
QTc interval ≤ 460 msec
No seizure disorder
No significant traumatic injury ≤ 4 weeks prior to registration
No clinically significant infection
No HIV-positivity
No second primary malignancy, except for carcinoma in situ of the cervix or nonmelanoma skin cancer, unless prior malignancy was diagnosed and treated ≥ 5 years with no subsequent evidence of recurrence
Patients with a history of low grade(Gleason score ≤ 6) localized prostate cancer will be eligible even if diagnosed \< 5 years prior to registration
No concurrent severe and/or uncontrolled medical conditions, including any of the following:
Cardiac arrhythmias
Angina pectoris uncontrolled with medication
Myocardial infarction within the past 3 months
Significant ECG abnormalities
Hypertension, labile hypertension, or history of poor compliance with anti-hypertensive medication
Congestive heart failure within the past 3 months, unless ejection fraction \> 40%
Interstitial pneumonia or extensive, symptomatic interstitial fibrosis of the lung
Poorly controlled diabetes
No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
No condition that impairs the ability to swallow AZD0530 tablets, including any of the following:
Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
Prior surgical procedures affecting absorption of AZD0530 tablets
Active peptic ulcer disease
No serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study
At least 4 weeks since prior major surgery (i.e., laparotomy) or open biopsy
At least 2 weeks since prior minor surgery
At least 4 weeks since any prior investigational ancillary therapy (i.e., utilized for a non-FDA-approved indication and in the context of a research investigation)
At least 7 days since prior use of strong inhibitors of CYP3A4 and no concurrent use for up to 7 days after discontinuation of AZD0530
Prior nonthoracic palliative radiotherapy allowed
Concurrent bisphosphonates for treatment of lytic metastatic bone disease allowed at the discretion of the treating physician
No concurrent prophylactic granulocyte colony-stimulating factor (i.e., G-CSF)
No concurrent products that stimulate thrombopoiesis
No concurrent St. John's wort
No other concurrent chemotherapy, immunotherapy, hormonal therapy,or radiotherapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

North Central Cancer Treatment GroupRochester, Minnesota

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2017. Always confirm current availability with the study team.

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