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

Phase 2

Withdrawn

• Conditions: Solid Tumor
• Interventions: Drug: Vistusertib(AZD2014)

• Registration Number: NCT03166904
• Lead Sponsor: Samsung Medical Center

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).

Detailed Description

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).

Study treatment will be continued until objective disease progression (unless other criteria for treatment discontinuation are met). Patients may continue vistusertib(AZD2014) beyond progression (according to RECIST 1.1), at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria.

If a patient discontinues study treatment prior to disease progression, they should continue to be assessed using RECIST 1.1 until disease progression and then followed up for survival.

Assessments for survival should be made every 8 weeks following objective disease progression. The details of first and subsequent therapies for cancer, after discontinuation of treatment, will be collected.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-25
• Study Start: 2018-03
• Primary Completion: 2018-06
• Study Completion: 2018-07-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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

2. Provision of tumor sample tumor sample tumor sample tumor sampletumor sample (from either a resection or biopsy)

3. Patients with RICTOR amplification through NGS.

4. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective reponse rate (ORR) by RECIST 1.1	12months

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of