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

Small Cell Lung Cancer Clinical Trial

— [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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03106155
• Other study ID #: 2017-01-003
• Status: Terminated
• Phase: Phase 2
• Start date: August 2, 2017
• Est. completion date: June 29, 2018

Study information

• Verified date: September 2018
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 29, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

[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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• vistusertib (AZD2014)
vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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