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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT03991494
Eligibility Criteria:
Key Inclusion Criteria:
1. Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available
2. A total body weight between 50 and 100 kg, inclusive at Screening
3. Measurable disease by CT/MRI
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
5. Adequate organ function
Key Exclusion Criteria:
1. Clinically significant cardiovascular disease
2. Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome.
3. Poor peripheral venous access
4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
5. Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03991494
Study Brief:
Protocol Section:
NCT03991494