Trial of Single Agent AZD2014 in RICTOR Amplified GC Patients as Second-line Therapy

• Status: Terminated
• Trial end date: 2018-11-16
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial of AZD2014 in RICTOR amplified or overexpressed GC patients as second-line chemotherapy AZD2014 50mg BD continuous schedule of a 28 day cycle

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center

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 )