Clinical Trials /

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

NCT03106155

Description:

[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

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification
  • Official Title: Phase II, Single-arm Study of Vistusertib (AZD2014) Monotherapy in Relapsed Small Cell Lung Cancer Patients Harboring RICTOR Amplification(SUKSE-D)

Clinical Trial IDs

  • ORG STUDY ID: 2017-01-003
  • NCT ID: NCT03106155

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
vistusertib (AZD2014)vistusertib (AZD2014)

Purpose

[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

Trial Arms

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

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective reponse rate (ORR) by RECIST 1.1
Time Frame:Up to 20 months
Safety Issue:
Description:Assessments to be performed using CT or MRI scans. To be measured according to RECIST 1.1

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

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