Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT03290092
Eligibility Criteria:
Inclusion Criteria:
* Have given, or their legal representative has given, written informed consent to participate
* Aged 16 years to 65 years inclusive
* Male or female
* Post-zygotic PIK3CA mutation
* Clinically stable in the opinion of the investigator
* Participant Pregnancy and contraception:
o Female participants of child bearing potential must use an effective method of contraception during treatment and for at least 3 months after the final dose of taselisib. Acceptable methods are:
* True abstinence (this must be the participant's usual and preferred lifestyle, not just for the duration of the trial)
* Oral contraceptive (either combined or progestogen alone)
* Contraceptive implant, injections or patches
* Vaginal ring
* Intrauterine device (IUD, coil or intrauterine system)
* Condom and cap
* Diaphragm plus spermicide
* A female participant of child bearing potential is defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 12 consecutive months if aged 55 years or older.
* Men must use one of the following, reliable forms to contraception for the entire duration of treatment and for 3 months after the final dose of taselisib:
* Condom plus spermicide even if female partner is using another method of contraception (Men should also use a condom to protect male partners, or female partners who are pregnant or breast feeding, from exposure to the Trial medicine in semen).
* True abstinence (this must be the participant's usual and preferred lifestyle, not just for the duration of the Trial)
Exclusion Criteria:
* Pregnant or breastfeeding
* HIV infection
* Hypersensitivity to taselisib or any of its excipients
* Any current medical disorder or medication likely to impair ability to follow the trial protocol safely and effectively
* Are concurrently taking an mTOR inhibitor or any other small molecule inhibitor of the PI3K-AKT signalling pathway
* Unable or unwilling to give informed consent
* Sirolimus or taselisib treatment in 12 weeks prior to screening
* Treatment with a strong inducer or inhibitor of CYP3A4 without the possibility to stop this medication within the week prior to the screening. This includes:
* Macrolide Antibiotics: clarithromycin, telithromycin, erythromycin, troleandomycin
* Gastrointestinal prokinetic agents: metoclopramide.
* Antifungals: itraconazole, ketoconazole, fluconazole, voriconazole, clotrimazole
* Calcium channel blockers: verapamil, diltiazem, nicardipine
* Grapefruit containing foods/drinks
* Anticonvulsants: carbamazepine, phenobarbital, phenytoin
* Antibiotics: rifampicin, rifabutin, rifapentine
* Herbal preparations: St. John's wort (Hypericum perforatum). Other drugs: bromocriptine, cimetidine, danazol, cyclosporine, lansoprazole, calcium containing antacids.
* Inability to attend trial visits
* If less than 3 months post- major surgery at screening
* Any past medical history of inflammatory bowel disease or chronic diarrhoea of unknown aetiology
* History of type 1 or type 2 diabetes mellitus requiring insulin, GLP-1 analogues or oral hypoglycaemic agents.
* History of inflammatory bowel disease, ischemic colitis, or colitis of unknown origin.
* Fasting blood glucose \> 6.9 mmol/l
* HbA1C \> 6%
* Long QT, congenital or acquired
* Active pneumonitis
* Patients who require daily supplemental oxygen
* Inadequate renal function defined as creatinine clearance or radioisotope GFR \< 60ml/min/1.73 m²
* Inadequate liver function defined as:
* Total bilirubin \> 2.0 x ULN or conjugated bilirubin \> 2.0 x ULN for age, and
* SGPT (ALT) or SGOT (AST) ≥ 1.5 x ULN for age, and
* Serum albumin \< 30 g/L
* Inadequate fasting LDL cholesterol \> 4.2 mmol/l
* Deprived of freedom by an administrative or court order, or benefiting from a system of legal protection (tutorship, curatorship or safeguard of justice).
* Not covered by health insurance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT03290092
Study Brief:
Protocol Section:
NCT03290092