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AzTrials

Small Cell Lung CancerPhase 2NCT03366675

AZD 2811 Monotherapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N3]

A Phase 2 study testing AZD2811 in people with Small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.

Terminated

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

Official record
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Trial summary

This study is a single arm, multi-center phase II study of AZD 2811 monotherapy in patients with relapsed small cell lung cancer (SCLC) as a second or third line therapy. Patients will continue to receive study treatment as described above, until they demonstrate objective disease progression (determined by RECIST… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
AZD2811
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2017to 29 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Provision of fully informed consent prior to any study specific procedures.
  • Patients must be ≥20 years of age.
  • Small cell lung cancer(SCLC) that has progressed during or after first-line therapy.
  • The 1st line regimen must have contained platinum based regimen.
  • Refractory to first-line chemotherapy or relapse within 6 months since the last dose of first-line chemotherapy
  • If the patient correspond to sensitive relapse (relapse more than 6 months since the last dose of first-line chemotherapy), she/he should get second-line treatment.
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  • Provision of tumor sample (from either archival or fresh biopsy)
  • Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • ECOG performance status of 0-2
  • Patients must have a life expectancy ≥ 3 months from proposed first dose date.
  • Patients must have acceptable bone marrow, liver and renal function measured within 28days prior to administration of study treatment as defined below:
  • Haemoglobin > 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • White blood cells (WBC) ≥ 3 x 109/L
  • Platelet count ≥100 x 109/L
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) except for subject with liver metastases for whom total bilirubin is ≤ 3 x ULN
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal(ULN) except for subject with liver metastases for whom AST(SGOT)/ALT(SGPT) is ≤ 5x ULN
  • Alkaline phosphatase(ALP) ≤ 2.5 x institutional upper limit of normal(ULN) except for subject with liver metastases for whom ALP is ≤ 5 x ULN. ALP is not exclusionary if due to the presence of bone metastasis and liver function is otherwise considered adequate in the investigator's judgement.
  • Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
  • Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72 a where F=0.85 for females and F=1 for males.
  • Albumin ≥ 33g/L
  • At least one measurable lesion that can be accurately assessed by imaging or physical examination.
  • Evidence of non-childbearing status for women of childbearing potential: A woman of childbearing potential must have a negative or urine pregnancy test at screening and confirmed prior to treatment on Cycle 1 Day 1
  • Female patients who are not of childbearing potential and fertile female patients of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding. Fertile female patients of childbearing potential should use enhanced methods of contraception from the time of screening until 6 months after discontinuing study treatment. Acceptable methods of contraception include: combined oral or transdermal contraceptives, copper-banded intra-uterine devices and vasectomised partner. All methods of contraception (with the exception of total abstinence) should be used in combination with the use of a condom by their male sexual partner for intercourse. Male patients should be asked to avoid unprotected sex with all sexual partners (by use of condoms) during the study, and for a washout period of 6 months after the last dose of study drug. Where a sexual partner of a male participant is a fertile female patient of childbearing potential, patients should avoid procreation for 6 months after completion of study drug treatment. Patients should refrain from donating sperm from the start of dosing until 6 months after discontinuing study treatment. If male patients wish to father children they should be advised to arrange for freezing of sperm samples prior to the start of study treatment

Who cannot join

  • Previous enrolment in the present study
  • More than two prior chemotherapy regimen for the treatment of small cell lung cancer
  • Previous treatment with Alisertib
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for >2 years.
  • Treatment with any investigational product during the last 14 days before the enrollment (or a longer period depending on the defined characteristics of the agents used).
  • Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment.
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  • Patient has had prescription or non-prescription drugs or other products known to be strong inhibitors/inducers of CYP3A4 which cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 weeks after the last dose of study drug. Washout periods vary between 1 to 5 weeks depending on the medication.
  • With the exception of alopecia, any ongoing toxicities (>CTCAE 4.03 grade 1) caused by previous cancer therapy.
  • Intestinal obstruction or CTCAE 4.03 grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
  • Resting ECG with measurable QTc > 470 msec on 3 or more time points within a 24 hour period or any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, immediate family history of long QT syndrome or unexplained sudden death under 40 years of age.
  • Patients with cardiac problem as follows: unstable angina pectoris, congestive heart failure, acute myocardial infarction, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias (patients with chronic rate controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).
  • Patients at risk of brain perfusion problems(e.g., carotid stenosis hypotension, including a fall in blood pressure of >20mm Hg)
  • Uncontrolled hypertension requiring clinical intervention.
  • Female patients who are breast-feeding or child-bearing
  • Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C
  • Major surgical procedures ≤28 days of beginning study treatment, or minor surgical procedures ≤7 days
  • Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases - defined as metastasis having no evidence of progression or haemorrhage for at least 2 weeks after treatment (including brain radiotherapy).

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical center

    Seoul

Other trials in South Korea

About this study

Official title: Phase II, Single-arm Study of AZD 2811 Monotherapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N3]

This study is a single arm, multi-center phase II study of AZD 2811 monotherapy in patients with relapsed small cell lung cancer (SCLC) as a second or third line therapy.

Patients will continue to receive study treatment as described above, until they demonstrate objective disease progression (determined by RECIST 1.1) or they meet any other discontinuation criteria.

Being tested
AZD2811
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

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

  • AZD2811Drug

    AZD2811 100mg/vial

Study groups in NCT03366675
Study groupRoleWhat they receive
AZD2811ExperimentalAZD2811 200mg IV QD CnD1 \& D4 every 4weeks
Receives: Drug: AZD2811

What is being measured

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

  1. Objective reponse rate (ORR) by RECIST 1.1

    Assessments to be performed using CT or MRI scans. To be measured

    Measured: up to 18months

Secondary outcomes (4)

  1. Duration of response

    Assessments to be performed using CT or MRI scans. To be measured

    Measured: up to 18months

  2. Disease control rate

    Assessments to be performed using CT or MRI scans. To be measured

    Measured: At 8 weeks

  3. Overall survival(OS)

    Kaplan-Meier method

    Measured: up to 18 months

  4. Progression-free survival(PFS)

    Kaplan-Meier method

    Measured: up to 18 months

Timeline

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

  1. First posted8 Dec 2017
  2. Study start1 Dec 2017
  3. Primary completion8 Oct 2018
  4. Study completion29 Oct 2018

Why it stopped: Early detection of the purpose of the study.

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366675
Sponsor's protocol ID
2017-10-071
Status last verified
Feb 2018
First submitted
27 Nov 2017
Last updated
27 Nov 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2811 in people with Small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.

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 24 inclusion and 17 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 27 Nov 2018. 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 South Korea. 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?

The study was stopped early (reason given: Early detection of the purpose of the study.). Results are not available in the source record.

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 reponse rate (ORR) by RECIST 1.1 (time frame: up to 18months). 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 NCT03366675.

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 27 Nov 2018.

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