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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT01708161
Eligibility Criteria:
Key inclusion criteria:
* Written informed consent.
* Patients aged ≥ 18 years (male or female).
* Patients with the following histologically/cytologically-confirmed advanced solid tumors with documented somatic PIK3CA mutations or amplifications in tumor tissue:
* Hormone receptor positive breast carcinoma
* Ovarian carcinoma
* Other tumors upon agreement with sponsor
* Adequate organ function
* Negative serum pregnancy test
Key exclusion criteria:
* Patients with known history of severe infusion reactions to monoclonal antibodies.
* Patients with primary CNS tumor or CNS tumor involvement.
* History of thromboembolic event requiring full-dose anti-coagulation therapy any time prior to enrollment.
* Clinically significant cardiac disease.
* History of another malignancy within last 2 years.
* Pregnant or nursing (lactating) women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01708161
Study Brief:
Protocol Section:
NCT01708161