Phase II Trial of AZD2014 in RICTOR Amplified Solid Cancer Patients Refractory to Standard Chemotherapy

NCT03166904 | Withdrawn Phase 2

• 1 other identifier: 2017-05-097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with RICTOR amplified refractory solid cancer will receive vistusertib(AZD2014). Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 16 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date).

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective reponse rate (ORR) by RECIST 1.1

  12months

Study Arms (1)

AZD2014

EXPERIMENTAL

Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle

Drug: Vistusertib(AZD2014)

Interventions

Vistusertib(AZD2014) DRUG

Vistusertib(AZD2014) is a selective dual mTOR kinase inhibitor targeting both mTORC1 (rapamycin sensitive) and mTORC2 (rapamycin insensitive) complexes of mammalian Target Of Rapamycin (mTOR).

Also known as: azd2014

AZD2014

Eligibility Criteria

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

You may qualify if:

• Advanced solid cancers (including histologically or cytologically documented gastric cancer, colorectal cancer, hepatoma, biliary tract cancers, pancreatic cancer and rare cancers.) that has progressed after standard chemotherapy.
• \- Rare cancers are defined as sarcoma, neuroendocrine carcinoma
• Provision of tumor sample tumor sample tumor sample tumor sampletumor sample (from either a resection or biopsy)
• Patients with RICTOR amplification through NGS.
• Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

You may not qualify if:

• Patients not having received recommended treatment-lines and chemotherapy regimen for the treatment of each tumor type in the advanced setting.
• Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K / mTOR activity.
• HER2 positive AGC patients (defined by HER2 3+ by immunohistochemistry or HER2 SISH +)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

vistusertib

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: MD,PhD

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

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 25, 2017
• Study Start: March 1, 2018
• Primary Completion: June 1, 2018
• Study Completion: July 31, 2018
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

KR (1)