Phase II trial of Vistusertib(AZD2014) single agent in TSC1or 2 null or TSC 1/2 mutation solid cancer patients refractory to standard chemotherapy

Not Applicable

Withdrawn

• Conditions: Neoplasms

• Registration Number: KCT0003961
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-06-17

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• Status: Withdrawn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.
4. Providing tumor samples (from ablation or biopsy)
5. A patient with TSC 1 or 2 deficiency by an IHC (defined as a defect in TSC 1 or TSC 2 as having no immunocology dye for the tumor).
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 treatments, patients should have acceptable bone marrow, liver, and new functions defined below.
– Hemoglobin = 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 day 1. The patient 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. Patients who can not swallow oral medication.
5. Prior major surgery within four weeks of registration.
6. Vistusertib (AZD 2014) : 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 (competitive): ketoconazole, itraconazole, indinavir, saquinovir, nelfinavir, atazanavir, amprenavir, fosamprenavir, troleandomycin, telithromycin, fluconazole, nefazodone, cimetidine, aprepitant, miconazole, fluvoxamine, P-glycoprotein, grapefruit juice, or seville oranges (1 week minimum wash-out period), amiodarone (27 week minimum wash-out period)
• Inhibitors (time dependent): erythromycin, clarithromycin, verapamil, ritonavir, diltiazem (2 week minimum wash-out period)
• Inducers: phenytoin, rifampicin, St. John's Wort, carbamazepine, dexamethasone, primidone, griseofulvin, carbamazepine, barbiturates, troglitazone, pioglitazone, oxcarbazepine, nevirapine, efavirenz, rifabutin (3 week minimum wash-out period) and phenobarbitone (5 week minimum wash-out period)
• Exposure to potent or moderate inhibitors or inducers of CYP2C8 if taken within the stated washout periods before the first dose of study treatment
• Inhibitors: Gemfibrozil, trimethoprim, glitazones, montelukast, quercetin (1 week minimum wash-out period)
• Inducers: Rifampicin (3 week minimum wash-out period)
• Exposure to strong or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment

Study & Design

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