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SCLCPhase 2NCT03428607

Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2]

A Phase 2 study testing AZD6738 and Olaparib in people with SCLC, run by Samsung Medical Center at 1 site in South Korea.

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

This study is a single arm, multi-center phase II study of AZD6738 and olaparib combination therapy in patients with relapsed small cell lung cancer (SCLC) as a second or third line chemotherapy. Patients will receive AZD6738 and olaparib combination therapy. The arm is composed of 45 patients. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
SCLC
What is being tested?
AZD6738 and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSouth Korea
Study dates
17 Oct 2018to 15 Jan 2021
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.
  • Subjects 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)
  • Subjects 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
  • Subjects must have a life expectancy ≥ 3 months from proposed first dose date.
  • Subjects must have acceptable bone marrow, liver and renal function measured within 28days prior to administration of study treatment as defined below:
  • Haemoglobin ≥10.0 g/dL with no blood transfusion the past 28days.
  • 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.
  • Subjects must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
  • Estimated creatinine clearance = (140-age [years]) x weight (kg) x Fa 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 subjects who are not of childbearing potential and fertile female subjects of childbearing potential who agree to use adequate contraceptive measures, who are not breastfeeding. For women, must agree to use a barrier method of birth control. must agree to use a barrier method of birth control for 3months after treatment stops.
  • Fertile male patients willing to use at least one medically acceptable form of birth control, and must not donate sperm, for the duration of the study, and for 6months after treatment stops.
  • Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to that part.

Who cannot join

  • Previous enrolment in the present study
  • More than two prior chemotherapy regimen for the treatment of small cell lung cancer
  • Any previous treatment with ATR inhibitor and PARP inhibitor, including olaparib
  • 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.
  • Subjects unable to swallow orally administered medication.
  • 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).
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  • Subjects 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.
  • Concomitant use of known sensitive CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong CYP3A4 inhibitor/inducer which cannot be discontinued to 2weeks prior to Day 1 of dosing(except for St. John's Wort, which is 3 weeks) and withheld throughout the study until 4weeks after the last dose of study drug, Co-administration of aprepitant or fosaprepitant or Pgp inhibitor/inducer during this study is prohibited Refer to the Section 8.3.2 and Appendix H for listing of all prohibited medications.
  • 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 4weeks before the enrollment.
  • Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
  • 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.
  • Subjects 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).
  • Subjects at risk of brain perfusion problems(e.g., carotid stenosis hypotension, including a fall in blood pressure of >20mm Hg)
  • Subjects with relative hypotension (< 100/60 mm Hg) or clinically relevant orthostatic
  • 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 subjects 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 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 2weeks after treatment.

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 AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2]

This study is a single arm, multi-center phase II study of AZD6738 and olaparib combination therapy in patients with relapsed small cell lung cancer (SCLC) as a second or third line chemotherapy.

Patients will receive AZD6738 and olaparib combination therapy. The arm is composed of 45 patients.

Read more

AZD6738 160mg QD per os administered for 7 days and olaparib 300mg BID per os administered daily. One cycle is considered of 28 days.

Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date, up to week 56, then every 12 weeks until objective disease progression (within a window of ± 7 days of the scheduled date).

Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue AZD6738 and olaparib beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria.

If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.

Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of AZD6738 and olaparib treatment, will be collected.

The imaging modalities used for RECIST 1.1 assessment will be CT or MRI scans of chest, abdomen and pelvis. RECIST 1.1 scans will be analysed by the investigator on site.

Patients may also be requested to provide tumour samples from the primary or metastatic tumours on progression to understand resistance mechanisms. Sample provision is optional and depend on the patient's will.

Conditions
SCLC
Being tested
AZD6738, Olaparib

What participants receive

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

  • AZD6738Drug

    AZD6738 160mg QD

  • OlaparibDrug

    Olaparib 300mg BID

Study groups in NCT03428607
Study groupRoleWhat they receive
AZD6738+OlaparibExperimentalAZD6738 160mg QD per os administered for 7 days and olaparib 300mg BID per os administered daily. One cycle is considered of 28 days.
Receives: Drug: AZD6738; Drug: Olaparib

What is being measured

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

  1. Objective response rate (ORR) by RECIST 1.1

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

    Measured: up to 18 months

Secondary outcomes (5)

  1. Duration of response

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

    Measured: up to 18 months

  2. Disease control rate

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

    Measured: At 8 weeks

  3. Overall survival

    Kaplan-Meier method

    Measured: up to 18 months

  4. progression-free survival

    Kaplan-Meier method

    Measured: up to 18 months

  5. Time to first relapse

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

    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 posted9 Feb 2018
  2. Study start17 Oct 2018
  3. Primary completion15 Jan 2021
  4. Study completion15 Jan 2021

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03428607
Sponsor's protocol ID
2017-10-074
Status last verified
Feb 2021
First submitted
5 Feb 2018
Last updated
18 Feb 2021
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 AZD6738 and Olaparib in people with SCLC, 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 26 inclusion and 20 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 18 Feb 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 response rate (ORR) by RECIST 1.1 (time frame: up to 18 months). 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 NCT03428607.

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 18 Feb 2021.

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