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

NCT03366675 | Terminated Phase 2 FDA Drug

• 1 other identifier: 2017-10-071
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 1.1) or they meet any other discontinuation criteria.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective reponse rate (ORR) by RECIST 1.1

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

  up to 18months

Secondary Outcomes (4)

• Duration of response

  up to 18months

• Disease control rate

  At 8 weeks

• Overall survival(OS)

  up to 18 months

• Progression-free survival(PFS)

  up to 18 months

Other Outcomes (1)

• Number of participants with Adverse Events as Assessed by CTCAE v4.03

  up to 18months

Study Arms (1)

AZD2811

EXPERIMENTAL

AZD2811 200mg IV QD CnD1 \& D4 every 4weeks

Drug: AZD2811

Interventions

AZD2811 DRUG

AZD2811 100mg/vial

AZD2811

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Samsung Medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

AZD2811

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 8, 2017
• Study Start: December 1, 2017
• Primary Completion: October 8, 2018
• Study Completion: October 29, 2018
• Last Updated: November 27, 2018

Record last verified: 2018-02

Locations

KR (1)