Phase II, Single-arm Study of Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations(SUKSES-B)

Samsung Medical Center1 site in 1 country15 target enrollmentAugust 2016

ConditionsSmall Cell Lung Cancer

InterventionsOlaparib

DrugsOlaparib

Overview

Phase: Phase 2
Intervention: Olaparib
Conditions: Small Cell Lung Cancer
Sponsor: Samsung Medical Center
Enrollment: 15
Locations: 1
Primary Endpoint: Objective response rate (ORR) by RECIST 1.1
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a single arm, multi-center phase II study of olaparib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited to BRCA 1/2 mutations, ATM deficiency or MRE11A mutations as second or third line chemotherapy.

Target subject population:

Patients with small cell lung cancer that have progressed following first-line platinum-based therapy. Patients must have imaging confirmed progression on 1st line chemotherapy for SCLC treatment, which must have contained platinum-based regimen, with at least one measurable lesion per RECIST 1.1.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

January 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Keunchil Park

professor, MD

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•Provision of informed consent prior to any study specific procedures
•Small cell lung cancer that satisfies one or more of the following conditions:
•BRCA1 or BRCA2 mutation, ATM deficiency, MRE11A mutation 2) Mutation of other HR(homologous recombination) pathway genes: BLM, NBN, RAD50, RAD52, RAD54L, RAD51, RAD51B, RAD51C, RAD51D, RECQL, RECQL4, RECQL5, RPA1, WRN etc.
•Small cell lung cancer 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.
•Patients (male/female) must be \> 20 years of age.
•Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
•ECOG performance status 0-1

Exclusion Criteria

•Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
•Previous enrolment in the present study
•Participation in another clinical study with an investigational product during the last 2 weeks (or a longer period depending on the defined characteristics of the agents used).
•Any previous treatment with a PARP inhibitor, including olaparib.
•More than two prior chemotherapy regimen for the treatment of small cell lung cancer. Pazopanib maintenance or immune checkpoint inhibitor (CTLA4, PD-1 or PD-L1 monoclonal antibody) is not considered as line of treatment.
•Patients with second primary cancer
•Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). 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 with study drug.
•Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
•Persistent toxicities (\>=CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy.
•Resting ECG with QTc \> 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.

Arms & Interventions

Olaparib 300 mg

Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days

Intervention: Olaparib

Outcomes

Primary Outcomes

Objective response rate (ORR) by RECIST 1.1

Time Frame: Up to 30 months

Secondary Outcomes

Duration of response(Up to 30 months)
Number of participants with Adverse Events as Assessed by CTCAE v4.03(Up to 30 months)
Disease control rate(at 12 weeks)
Overall survival (OS)(Up to 30 months)
Progression-free survival (PFS)(Up to 30 months)