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

Not Applicable

Withdrawn

• Conditions: Neoplasms

• Registration Number: KCT0003954
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Provide a complete consent form for testing before any clinical testing specific procedure is carried out.
2. The patient must be over 18 years old.
3. Advanced solid cancer developed after standard chemotherapy (including colon cancer, liver cancer, cirrhology, pancreatic cancer and rare cancer).
– Rare cancers are defined as sarcoma, neuropath, melanoma, melanoma, myelasis, prostate cancer and bladder cancer.
– Standard chemotherapy is defined as the chemotherapy recommended by an expert or guideline for each type of tumor.
– The preceding chemotherapy accepted in this clinical trial plan is a chemical therapy preparation that includes immunolization therapy (pembrolizumab, ramucirumab, etc.).
4. Providing tumor samples (from ablation or biopsy)
5. Patients with RICTOR amplification by NGS. (The NUMBER value of NGS CNV Inspection Copy GAIN is defined as 5 or higher)
6. Patients with the will and ability to comply with the clinical trial plan during the clinical trial period, including treatment and scheduled visits and examinations.
7. ECOG performance status 0-1.
8. Patients must have an expected maximum of three months from the date of initial administration.
9. When measured within 28 days prior to the initial administration of clinical trial treatment, patients shall have acceptable bone marrow, liver, and new functions defined as follows :
– Hemoglobin = 9. 9.0 (Blood transfusion allowed)
– Absolute number of hosters (ANC) = 1.5 x 109 / L
– White blood cells > 3 x 109 / L
– Number of platelets = 100 x 109 / L (transfusion allowed)
– Total bilirubin = 1.5 x normal upper limit of test organization (ULN)
– Unless there is liver transfer, AST (SGOT) / ALT (SGPT) = 2.5 x test organization normal upper limit, if liver transfer is present, then = 5 x ULN
– serum creatinine = 1.5 x test engine ULN
10. There is at least one measurable lesion that can be accurately measured by image or physical examination in the baseline and follow-up visits.
11. Voice of urine or serum pregnancy test is negative within 28 days of clinical trial treatment and confirmed before the first day of administration. Patients with childbearing should not be using appropriate contraception (two reliable methods), Alternatively, patients must have evidence of non-child by meeting one of the following criteria in screening :
- Menopause - After – defined as a non-monthly for at least 12 months after age 50 and all foreign hormone treatments stop.
- Records of non-translational surgical infertility caused by hysterectomy, amanosomy, or double-defection ; however, it is not an intractive technique

Exclusion Criteria

1. Patients without recommended treatment order and chemotherapy for each type of tumor in progressive situations.
2. Prior treatment of PI KA, AKT or ttoneunOR inhibitor or agents with mixed PI PIOR activity.
3. A patient with other primary cancers. Exception : properly treated non-metomalaric skin cancer, epithelial cancer in a fully treated cervix, or other solid cancers that have been completely cured for five years without proof of disease.
4. EHR2 positive AGC patient (defined by immune tissue chemistry as EHR2 3 + or EHR2 SISH +)
5. Patients who can not swallow oral medication.
6. Prior major surgery within four weeks of registration.
7. Vistusertib (AZD 2014) : Strong or moderate inhibition of CY CYP4, if taken within the specified period of rest prior to the initial administration of clinical trial treatment
- Inhibitor, citoconathor, itraconazole, indinavir, saquinovire, nelfinavir, arazanavir, ampravir, amprear,
- Inhibitor (time-dependent) : erythromycin, clarithromycin, verapamil, ritonavir, diltiazem
- Devators : phenytoine, rifampicin, St. John`s wort, carbamacepine, dexamethasone, primidone, griseon
- Exposure to strong or moderate inhibitors or inducements of CY CYP8 if taken within the specified period of rest prior to the initial administration of clinical trial treatment
- Suppressant : Gemfibrozil, trimethoprim, glitazones, montelukast, quercetin
- Inducer : Rifampicin (minimum of 3 weeks holiday)
- If taken within the specified period of rest prior to the initial administration of clinical trial treatment, it will be subjected to strong or medium-range inhibitors or inducements of CY CYP4
8. In progress toxicity caused by previous chemotherapy (> CTCAE grade 1), excluding hair loss.
9. intestinal obstruction or CTCAE Grade 3 or upper 4 GI haemorrhage within 4 weeks of registration.
10. Family history of ECG or QT extension syndrome during rest, which shows at least two point-of-view measurements at least once in 24 hours.
11. . Patient with heart disease : heart disease, hypertension currently not regulated (BP = 155095 mm Hg), Left ventricular pressure measured by echocardiography, and
12. If the spinal cord pressure or the patient's neurological symptoms are minimal in patients who do not need active or treated brain cells or have treated brain cells, and there is a stable disease (at least one month of follow-up)
13. Women who are breastfeeding or pregnant
14. Evidence of severe or uncontrolled systemic diseases, active infections, active bleeding disease, or transplants, including patients who are known to have hepatitis B, hepatitis C or HIV
15. Patient with monomania (3 + on dipstick analysis)

* 3.3 Criteria for elimination and suspension of clinical trials
Test subjects may be dropped and interrupted in clinical trials (i.e. from additional drugs or clinical testing procedures) because :
- If the tester believes that continuing the clinical trial at the patient's request could be harmful to the well-being of the test subjects, for example, if the standards of pregnancy or mental illness are
- Treatment related adverse events have delayed the first day of treatment > 28 days. If delayed for 28 days other than for treatment related adverse reactions, patients may continue to receive medication if they are benefiting from clinical benefits.
- If participants refuse further clinical trial treatment or withdraw their consent to participate in the clinical trial.
In the following situations, the

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified