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
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
Interventions
Drug | Synonyms | Arms |
---|
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
Name | Type | Description | Interventions |
---|
vistusertib (AZD2014) | Experimental | vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours | |
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: | Terminated |
Lead Sponsor: | Samsung Medical Center |
Last Updated
September 20, 2018