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 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 1:37 AM
NCT ID:
NCT03914794
Eligibility Criteria:
Inclusion Criteria:
* Prior histologically confirmed low- or intermediate-risk non-muscle invasive urothelial carcinoma of the bladder (NMIBC) defined according to the following characteristics:
* Low Risk
* Initial tumor with all of the following:
* Solitary tumor
* Ta tumor
* Low-grade
* \<3 cm
* No CIS
* Intermediate Risk
\--- All tumors not defined in the two adjacent categories (between the category of low- and high-risk)
* High Risk
* T1 tumor
* High-grade
* CIS
* Multiple and recurrent and large (\>3 cm) Ta low-grade tumors (all conditions must be met for this point on Ta low-grade tumors)
* Documented tumor recurrence as noted in standard of care follow up cystoscopy.
* ECOG (WHO) performance status 0-2
* Age ≥ 18 years old
* Patients must have the following laboratory values:
* White blood cell count (WBC) \> 3.0 K/mm3
* Absolute neutrophil count (ANC) ≥ 1.5 K/mm3
* Platelets ≥ 100 K/mm3
* Hemoglobin (Hgb) ≥ 9 g/dL
* Serum total bilirubin: ≤ 1.5 x ULN
* ALT and AST ≤ 3.0 x ULN
* Serum calcium \< ULN
* Serum phosphate \< ULN
* Serum creatinine ≤ 1.5 x ULN or serum creatinine \> 1.5 - 3 x ULN if calculated creatinine clearance (CrCl) is ≥ 30 mL/min using the modified Cockcroft-Gault equation
* Patients who give a written informed consent obtained according to local guidelines
Exclusion Criteria:
* Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma.
* Patients with high grade urothelial carcinoma on their most recent urine cytology.
* Patients with another active second malignancy other than non-melanoma skin cancers and biochemical relapsed prostate cancer. (Patients that have completed all necessary therapy and are considered to be at less than 30% risk of relapse are not considered to have an active second malignancy and are eligible for enrollment.)
* Patients who have received the last administration of an anti-cancer therapy including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy
* Patients who have received prior selective fibroblast growth factor receptor targeting agents (i.e. pemigatinib, dovitinib, BGJ398, AZD4547, JNJ-42756493, etc.).
* Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who have not recovered from radiotherapy toxicities
* Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures (i.e. TURBT), percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03914794
Study Brief:
Protocol Section:
NCT03914794