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

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

[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

Study Overview

• Status: Terminated
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: vistusertib (AZD2014)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

[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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: vistusertib (AZD2014); vistusertib (AZD2014), 50 mg,BID, per os, every 12 hours	Drug: vistusertib (AZD2014); vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2017
• Primary Completion (ACTUAL): May 3, 2018
• Study Completion (ACTUAL): June 29, 2018

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 20, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 2017-01-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No