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Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification ([SUKSES-D])

Primary Purpose

Small Cell Lung Cancer

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
vistusertib (AZD2014)
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

[Inclusion Criteria]

  • Provision of informed consent prior to any study specific procedures
  • Men and women aged at least 18 years
  • Small cell lung cancer harboring RICTOR amplification
  • Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks
  • Minimum life expectancy of 12 weeks
  • Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below:
  • At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits.
  • No history of non-autologous bone marrow transplant.

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.

Sites / Locations

  • Samsung Medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vistusertib (AZD2014)

Arm Description

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

Outcomes

Primary Outcome Measures

Objective reponse rate (ORR) by RECIST 1.1
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1

Secondary Outcome Measures

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

Full Information

First Posted
April 4, 2017
Last Updated
September 18, 2018
Sponsor
Samsung Medical Center
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03106155
Brief Title
Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification
Acronym
[SUKSES-D]
Official Title
Phase II, Single-arm Study of Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification(SUKSE-D)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Why Stopped
Decision of IP support organization
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Vistusertib monotherapy (50 mg BID per os every 12 hours)
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vistusertib (AZD2014)
Arm Type
Experimental
Arm Description
vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours
Intervention Type
Drug
Intervention Name(s)
vistusertib (AZD2014)
Intervention Description
vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks.
Primary Outcome Measure Information:
Title
Objective reponse rate (ORR) by RECIST 1.1
Description
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Time Frame
Up to 20 months
Secondary Outcome Measure Information:
Title
Duration of response
Description
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Time Frame
Up to 20 months
Title
Disease control rate
Description
Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1
Time Frame
at 12 weeks
Title
Overall survival (OS)
Description
Kaplan-Meier method
Time Frame
Up to 20 months
Title
Progression-free survival (PFS)
Description
Kaplan-Meier method
Time Frame
Up to 20 months
Title
Number of participants with Adverse Events as Assessed by CTCAE v4.03
Description
CTCAE v4.03
Time Frame
Up to 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
[Inclusion Criteria] Provision of informed consent prior to any study specific procedures Men and women aged at least 18 years Small cell lung cancer harboring RICTOR amplification Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no deterioration over the previous 2 weeks Minimum life expectancy of 12 weeks Patients must have acceptable bone marrow, liver and renal function measured within 14 days prior to administration of study treatment as defined below: At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and follow up visits. No history of non-autologous bone marrow transplant. 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.
Facility Information:
Facility Name
Samsung Medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

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

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