Clinical Trials /

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

NCT03166904

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).

Related Conditions:
  • Biliary Tract Neoplasm
  • Colorectal Carcinoma
  • Gastric Carcinoma
  • Hepatocellular Carcinoma
  • Malignant Solid Tumor
  • Neuroendocrine Carcinoma
  • Pancreatic Carcinoma
  • Sarcoma
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Trial of AZD2014 in RICTOR Amplified Solid Cancer Patients Refractory to Standard Chemotherapy
  • Official Title: AZD2014 in RICTOR Amplified Solid Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2017-05-097
  • NCT ID: NCT03166904

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
Vistusertib(AZD2014)azd2014AZD2014

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
AZD2014ExperimentalVistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle
  • Vistusertib(AZD2014)

Eligibility Criteria

        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.

        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 +)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective reponse rate (ORR) by RECIST 1.1
Time Frame:12months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Samsung Medical Center

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