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 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT01928459
Eligibility Criteria:
Inclusion Criteria:
* Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
* Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
* Measurable disease defined by RECIST v1.1
* ECOG performance status of ≤2
Exclusion Criteria:
* Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
* Colorectal cancer (for patients enrolled to expansion part)
* Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
* Use of medications that increase serum levels of phosphorus and/or calcium
* Inorganic phosphorus outside of normal limits
* Total and ionized serum calcium outside of normal limits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01928459
Study Brief:
Protocol Section:
NCT01928459