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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT03954366
Eligibility Criteria:
Inclusion Criteria (All patients):
* Willing to sign the ICF and to comply with the study restrictions
* Body mass index (BMI) 18.0 to 35.0 kg/m2
* Histologically or cytologically confirmed advanced solid tumor
* Patients who, in the opinion of the Investigator, could potentially benefit from treatment with rucaparib
* ECOG performance status less than or equal to 1
* Adequate organ function
Inclusion Criteria (Arm A):
\- Male or female patients ≥ 18 years of age
Inclusion Criteria (Arm B):
\- Female patients ≥ 18 years of age
Exclusion Criteria (All patients):
* Specific cancer treatments within 14 days prior to Day 1
* Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, acute coronary syndrome, cardiac angioplasty, stenting, or poorly controlled hypertension within the last 3 months prior to screening
* Pre-existing duodenal stent, recent or existing bowel obstruction
* Untreated or symptomatic central nervous system (CNS) metastases. Patients with treated asymptomatic CNS metastases are eligible
* Known HIV or AIDS-related illness, acute or history of chronic hepatitis B or C
* Female patients who are pregnant or breastfeeding
* Participation in another investigational drug trial within 30 days prior to Day 1 or exposure to more than 3 new investigational agents within 12 months prior to Day 1
* Presence of active infection requiring antibiotics
* Active second malignancy
* History of drug abuse (including alcohol)
Exclusion Criteria (Arm A):
* Current use of rosuvastatin or any other statin
* History of hypersensitivity to rosuvastatin
* Current, or history of, clinically significant myopathy
Exclusion Criteria (Arm B):
* Current use of any 1 of the contraceptive drugs or previous contraceptive implants or depot injections, which may still be clinically effective
* History of hypersensitivity to ethinylestradiol or levonorgestrel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03954366
Study Brief:
Protocol Section:
NCT03954366