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

NCT03106155 | Terminated Phase 2

• 1 other identifier: 2017-01-003
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of response

  Up to 20 months

• Disease control rate

  at 12 weeks

• Overall survival (OS)

  Up to 20 months

• Progression-free survival (PFS)

  Up to 20 months

• Number of participants with Adverse Events as Assessed by CTCAE v4.03

  Up to 20 months

Study Arms (1)

vistusertib (AZD2014)

EXPERIMENTAL

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

Drug: vistusertib (AZD2014)

Interventions

vistusertib (AZD2014) DRUG

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

vistusertib (AZD2014)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Samsung Medical center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

vistusertib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Vistusertib monotherapy (50 mg BID per os every 12 hours)

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: August 2, 2017
• Primary Completion: May 3, 2018
• Study Completion: June 29, 2018
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

KR (1)