Clinical trial NCT03061708 (phase 2, status: terminated)
Conditions: stomach neoplasms
ICD codes: D13.1, C16.9, C16.1, C16.2, D37.1, C16.8, C16.5
Drugs: azd2014
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    lack of efficacy
  
Eligibility criteria:

        Inclusion Criteria:

          1. Provision of fully informed consent prior to any study specific procedures.

          2. Patients must be ≥20 years of age.

          3. Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after
             firstline therapy.

          4. Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months
             prior to starting the 1st line therapy.

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

          6. Patients with RICTOR amplification or overexpression through the VIKTORY trial.

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

          8. ECOG performance status 0-2.

          9. Patients must have a life expectancy ≥ 3 months from proposed first dose date.

         10. Patients must have acceptable bone marrow, liver and renal function -

         11. At least one measurable lesion that can be accurately assessed by imaging or physical
             examination at baseline and following up visits.

         12. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed
             prior to treatment on day 1.

        Exclusion Criteria:

          1. More than one prior chemotherapy regimen for the treatment of gastric cancer in the
             advanced setting.

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

          3. Patients with second primary cancer,

          4. Patients unable to swallow orally administered medication.

          5. Previous major surgery within 4weeks prior to enrollment.

          6. For 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
             Inhibitors

          7. Exposure to potent or moderate inhibitors or inducers of CYP2C8 if taken within the
             stated washout periods before the first dose of study treatment

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

          9. Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks
             before the enrollment.

         10. Resting ECG with measurable QTcB > 450 msec on 2 or more time points within a 24 hour
             period or family history of long QT syndrome.

         11. Patients with cardiac problem

         12. Active or untreated brain metastases or spinal cord compression Patients with treated
             brain metastases or spinal cord compression are eligible if they have minimal
             neurologic symptoms, evidence of stable disease (for at least 1 month) or response on
             follow-up scan, and require no corticosteroid therapy for ≥ 1 week.

         13. Female patients who are breast-feeding or child-bearing

         14. Any evidence of severe or uncontrolled systemic disease, active infection, active
             bleeding diatheses or renal transplant, including any patient known to have hepatitis
             B, hepatitis C or human immunodeficiency virus (HIV)

         15. Patients with proteinuria (3+ on dipstick analysis )