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

Sponsor
Samsung Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03166904
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
5
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycleVistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
AZD2014 in RICTOR Amplified Solid Cancer
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
Jul 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: AZD2014

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

Drug: Vistusertib(AZD2014)
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).
Other Names:
  • azd2014

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective reponse rate (ORR) by RECIST 1.1 [12months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

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

    2. Patients with RICTOR amplification through NGS.

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

    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 +)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jeeyun Lee, MD,PhD, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT03166904
    Other Study ID Numbers:
    • 2017-05-097
    First Posted:
    May 25, 2017
    Last Update Posted:
    May 20, 2019
    Last Verified:
    May 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 20, 2019