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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT03092934
Eligibility Criteria:
Inclusion Criteria:
* Have received at least 1 but no more than 4 prior systemic therapies
* Have adequate organ function
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have estimated life expectancy greater than or equal to (≥)12 weeks
* Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
* Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
* Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
* Male participants must use a barrier method of contraception during the study and for the following 3 months
Phase 1
* Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)
Phase 2
* Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
* Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:
* Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy
* Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
* Triple negative breast cancer (TNBC) and failed standard therapy
* Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy
* Other solid tumor type that has been approved by the sponsor
Exclusion Criteria:
* Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
* Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03092934
Study Brief:
Protocol Section:
NCT03092934