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Phase II Trial of Vistusertib(AZD2014) Single Agent in TSC1or 2 Null or TSC 1/2 Mutation Solid Cancer Patients Refractory to Standard Chemotherapy

NCT03166176

Description:

Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014) monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Withdrawn

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Trial of VistusertibAZD2014) Single Agent in TSC1or 2 Null or TSC 1/2 Mutation Solid Cancer Patients Refractory to Standard Chemotherapy
  • Official Title: SAMSUNG MEDICAL CENTER

Clinical Trial IDs

  • ORG STUDY ID: 2017-05-096
  • NCT ID: NCT03166176

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
Vistusertib(AZD2014)AZD2014

Purpose

Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014) monotherapy. Study-arm is composed of 27 patients. Vistusertib(AZD2014) 50mg BD continuous schedule of a 28 day cycle as a monotherapy

Detailed Description

      Patients with TSC1/2 mutated refractory solid cancer will receive vistusertib(AZD2014)
      monotherapy. Study-arm is composed of 27 patients.

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

Trial Arms

NameTypeDescriptionInterventions

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.

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

          3. Patients with TSC1or 2 null or TSC 1/2 mutation through IHC.

          4. Patients must have acceptable bone marrow, liver and renal function measured within 28
             days prior to administration of study treatment as defined below:

               -  Haemoglobin ≥9.0 g/dL (transfusion allowed)

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

               -  White blood cells (WBC) > 3 x 109/L

               -  Platelet count ≥100 x 109/L (transfusion allowed)

               -  Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)

               -  AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver
                  metastases are present in which case it must be ≤ 5x ULN

               -  Serum creatinine ≤1.5 x institutional ULN

        Exclusion Criteria:

          1. Any previous treatment with PIK3CA, AKT or mTOR inhibitor or agents with mixed PI3K /
             mTOR activity.

          2. For vistusertib(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 With the exception of
             alopecia, any ongoing toxicities (>CTCAE grade 1) caused by previous cancer therapy.

          3. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks
             before the enrollment.
      
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:To investigate the efficacy and safety of vistusertib(AZD2014) single agent as salvage therapy in patients with TSC1or 2 null or TSC 1/2

Details

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

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