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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05159518
Eligibility Criteria:
Inclusion Criteria:
* Tumor types under study
1. Selected sarcomas with a documented gene fusion
2. Castrate resistant prostate cancer (CRPC)
3. Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer
4. Non-small cell lung cancer (NSCLC)
5. MYC amplified solid tumors
* Must have measurable disease per RECIST 1.1; participants with CRPC or sarcoma may have nonmeasurable but evaluable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
* Adequate organ function
* Must provide tumor tissue sample to the central laboratory for biomarker analysis
* Participants must have recovered from the effects of prior cancer-related therapy, radiotherapy, or surgery to ≤ Grade 1
Exclusion Criteria:
* Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression
* have a corrected QT interval \>480 msec from prior or baseline
* have impaired cardiac function or clinically significant cardiac disease
* Treatment with strong inhibitors or inducers of CYP3A4
* Prior exposure to a CDK9 inhibitor
* History of another malignancy except for:
1. Curatively treated malignancy with no known active disease
2. Curatively treated non-melanoma skin cancer without evidence of disease
3. Curatively treated carcinoma in situ without evidence of disease
* have undergone major surgery within 2 weeks prior to Week 1 Day 1
* have had chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 28 days (whichever is shorter) prior to administration of the first dose of study drug on Week 1 Day 1.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05159518
Study Brief:
Protocol Section:
NCT05159518