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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01508104
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable, and for which standard/curative measures do not exist by RECIST 1.1 measureable lesion which is not declining
* Age ≥ 18 years old at the day of consenting to the study
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate bone marrow and organ function as defined by laboratory values
Exclusion Criteria:
* Previous treatment with PI3K inhibitors
* Concurrent malignancy or has a malignancy within 3 years of study enrollment, (with the exception of adequately treated basal or squamous cell carcinoma or cervical carcinoma in situ)
* Concurrently using other approved or investigational antineoplastic agent
* Currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, hormonal therapy, etc.)
* Poorly controlled diabetes mellitus (HbA1c \> 8 %)
* Chronic treatment with systemic steroids or another immunosuppressive agent
* Active cardiac disease
* Inadequately controlled hypertension (i.e, SBP \>180 mmHg or DBP \>100mmHg)
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea grade ≥ 2, malabsorption syndrome, or small bowel resection)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01508104
Study Brief:
Protocol Section:
NCT01508104