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Extensive Stage Small Cell Lung CancerPhase 2NCT00528645

AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer

A Phase 2 study testing saracatinib in people with Extensive Stage Small Cell Lung Cancer and Lung Metastases, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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
23 participants
Where
1 siteUnited States
Study dates
Nov 2007to May 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 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
Show all 56Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Central Cancer Treatment Group

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Study of the c-SRC Inhibitor AZD0530 After Four Cycles of Cytoreductive Chemotherapy for Patients With Extensive Stage Small Cell Lung Carcinoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the 12-week progression-free survival rate of patients with extensive stage small cell lung cancer treated with AZD0530.

SECONDARY OBJECTIVES:

  1. To determine the response rate in patients treated with this drug. II. To determine the overall survival and time-to-progression in patients treated with this drug.

III. To determine the adverse events of AZD0530 in these patients IV. To determine the effect of AZD0530 treatment on levels of circulating tumor cells in these patients.

  1. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug.

VI. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug.

TERTIARY OBJECTIVES:

  1. To determine the effect of AZD0530 treatment on levels of circulating tumor cells.

II. To determine potential predictive markers of response in circulating tumor cells after treatment with this drug.

III. To evaluate the rate of tumor marker (i.e., circulating tumor cells) stabilization in patients treated with this drug.

OUTLINE: Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.

After completion of study therapy, patients are followed periodically for up to 2 years.

Being tested
saracatinib
Medical subject headings
Pleural Effusion, Malignant, Small Cell Lung Carcinoma

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 NCT00528645
Study groupRoleWhat they receive
Treatment (saracatinib)ExperimentalPatients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.
Receives: Drug: saracatinib

What is being measured

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

  1. Progression-free Survival Rate at 12 Weeks

    The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate.

    Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline.

    Measured: 12 weeks

Secondary outcomes (3)

  1. Overall Survival

    Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: From registration to death due to any cause, assessed up to 2 years

  2. Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)

    Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart..

    Measured: After every other 21-day cycle, up to 2 years.

  3. Progression Free Survival

    Progression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: From registration to documentation of disease progression or death, assessed up to 2 years

Timeline

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

  1. First posted12 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionNov 2008
  4. Study completionMay 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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528645
Sponsor's protocol ID
NCI-2012-01831
Other IDs
NCI-2012-01831, NCCTG-N0621, CDR0000563952, N0621, N0621, U10CA025224
Status last verified
Nov 2017
First submitted
10 Sep 2007
Last updated
7 Dec 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing saracatinib in people with Extensive Stage Small Cell Lung Cancer and Lung Metastases, run by National Cancer Institute (NCI) at 1 site 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 56 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: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 11 Feb 2014). 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?

Progression-free Survival Rate at 12 Weeks (time frame: 12 weeks). 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 NCT00528645.

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 7 Dec 2017.

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