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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT04865159
Eligibility Criteria:
Inclusion Criteria:
1. At least 18 years of age.
2. Advanced solid tumor malignancies for whom no other therapy or intervention is available
3. Confirmation of measurable disease by RECIST v1.1
4. No uncontrolled hypertension, defined as \>140/90 mm Hg
5. A normal 12-lead ECG
6. At least two weeks since the last systemic anticancer therapy regimen prior to Cycle 1 Day 1; this includes radiation therapy.
7. ECOG performance status of 0-2.
8. Acceptable liver, renal and hematological function
9. Other protocol defined inclusion criteria may apply.
Exclusion Criteria
1. Has disease that is suitable for therapy administered with curative intent.
2. Ongoing treatment with another anticancer agent indicated for the malignancy for which the subject is enrolling into the study (excluding adjuvant hormonal therapy for breast cancer and hormonal treatment for castration sensitive prostate cancer).
3. History of cardiomyopathy, unstable angina within prior 6 months, myocardial infarction within prior 6 months, cerebrovascular attack within prior 6 months, history of New York Heart Association grade III or greater congestive heart failure, or current serious cardiac arrhythmia requiring medication.
4. Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
5. Major surgery, other than diagnostic surgery, within 14 days prior to Cycle 1 Day 1, without complete recovery.
6. Active, uncontrolled bacterial, viral or fungal infections requiring systemic therapy.
7. Other protocol defined exclusion may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04865159
Study Brief:
Protocol Section:
NCT04865159