Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy

NCT03061708 | Terminated Phase 2 DMC

• 1 other identifier: 2016-08-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial of AZD2014 in RICTOR amplified or overexpressed GC patients as second-line chemotherapy AZD2014 50mg BD continuous schedule of a 28 day cycle

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) by RECIST 1.1

  6 months

Study Arms (1)

AZD2014 50mg BD continuous schedule of a 28 day cycle

EXPERIMENTAL

AZD2014 50mg BD continuous schedule of a 28 day cycle

Drug: AZD2014

Interventions

AZD2014 DRUG

mTOR inhibitor

AZD2014 50mg BD continuous schedule of a 28 day cycle

Eligibility Criteria

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

You may qualify if:

• Provision of fully informed consent prior to any study specific procedures.
• Patients must be ≥20 years of age.
• Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after firstline therapy.
• Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the 1st line therapy.
• Provision of tumor sample (from either a resection or biopsy)
• Patients with RICTOR amplification or overexpression through the VIKTORY trial.
• Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
• ECOG performance status 0-2.
• Patients must have a life expectancy ≥ 3 months from proposed first dose date.
• Patients must have acceptable bone marrow, liver and renal function -
• At least one measurable lesion that can be accurately assessed by imaging or physical examination at baseline and following up visits.
• Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1.

You may not qualify if:

• More than one prior chemotherapy regimen for the treatment of gastric cancer in the advanced setting.
• Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
• Patients with second primary cancer,
• Patients unable to swallow orally administered medication.
• Previous major surgery within 4weeks prior to enrollment.
• For AZD2014: Exposure to potent or moderate inhibitors or inducers of CYP3A4/5 if taken within the stated washout periods before the first dose of study treatment Inhibitors
• Exposure to potent or moderate inhibitors or inducers of CYP2C8 if taken within the stated washout periods before the first dose of study treatment
• With the exception of alopecia, any ongoing toxicities (\>CTCAE grade 1) caused by previous cancer therapy.
• Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
• Resting ECG with measurable QTcB \> 450 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
• Patients with cardiac problem
• Active or untreated brain metastases or spinal cord compression Patients with treated brain metastases or spinal cord compression are eligible if they have minimal neurologic symptoms, evidence of stable disease (for at least 1 month) or response on follow-up scan, and require no corticosteroid therapy for ≥ 1 week.
• Female patients who are breast-feeding or child-bearing
• Any evidence of severe or uncontrolled systemic disease, active infection, active bleeding diatheses or renal transplant, including any patient known to have hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
• Patients with proteinuria (3+ on dipstick analysis )

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

vistusertib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jeeyun Lee, Md,PhD

  SamsungMedicalCenter

  PRINCIPAL INVESTIGATOR

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: professor

Model Details: AZD2014 50mg BD continuous schedule of a 28 day cycle

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 23, 2017
• Study Start: February 1, 2017
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

KR (1)