Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification

Phase 2

Terminated

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: vistusertib (AZD2014)

• Registration Number: NCT03106155
• Lead Sponsor: Samsung Medical Center

Brief Summary

\[Study Design\] This study is a single arm, multi-center phase II study of vistusertib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring RICTOR amplification. Patients will receive vistusertib monotherapy (50 mg BID per os every 12 hours) until they demonstrate objective disease progression or they meet any other discontinuation criteria.

\[Primary Objective\] To investigate the efficacy of vistusertib monotherapy in patients with relapsed SCLC patients harboring RICTOR amplification as 2nd or 3rd line therapy

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Study Start: 2017-08-02
• Primary Completion: 2018-05-03
• Study Completion: 2018-06-29
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

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Exclusion Criteria

• Participation in another clinical study with an investigational product during the last 21 days.
• Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment. Prior use of an investigational monoclonal antibody therapy within 3 months.
• Major surgery within 4 weeks prior to study entry (excluding placement of vascular access), or minor surgery (excluding tumour biopsies) within 14 days of first dose of study treatment.
• Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix 1)
• Exposure to specific substrates of the drug transporters OATP1B1, OATP1B3, MATE1 and MATE2K within the appropriate wash-out period
• Any haemopoietic growth factors within 14 days prior to receiving study treatment.
• Pre-treatment with other PI3K, AKT, dual PI3K/mTRO and mTOR inhibitors
• Spinal cord compression and/or brain metastases unless asymptomatic or treated and stable off steroids for at least 4 weeks prior to start of study treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vistusertib (AZD2014)	vistusertib (AZD2014)	vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours

Primary Outcome Measures

Name	Time	Method
Objective reponse rate (ORR) by RECIST 1.1	Up to 20 months	Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events as Assessed by CTCAE v4.03	Up to 20 months	CTCAE v4.03
Duration of response	Up to 20 months	Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Disease control rate	at 12 weeks	Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Overall survival (OS)	Up to 20 months	Kaplan-Meier method
Progression-free survival (PFS)	Up to 20 months	Kaplan-Meier method

Trial Locations

Locations (1)

Samsung Medical center; 🇰🇷 Seoul, Korea, Republic of