Clofarabine Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1/2 Dose-Escalation Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This phase 1/2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease

• Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy

• Age ≥ 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Absolute neutrophil count (ANC) greater than or equal to 1500.

• White blood cell (WBC) count greater than 3.0.

• Platelets greater than or equal to 100.

• Hemoglobin greater than 9.0 g/dL.

• Adequate hepatobiliary function as indicated by the following laboratory values: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN

• Adequate renal function as indicated by the following laboratory values: Serum creatinine ≤ 1.0 mg/dL; if serum creatinine \> 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 mL/min/1.73 m\^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation

• Adequate cardiac function (NYHA cardiac III-IV excluded)

• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment

• Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment

• Willing and able to provide informed consent

Locations
Other Locations
Austria
Department of Urology, Medical University of Vienna
RECRUITING
Vienna
Contact Information
Primary
Ekaterina Laukhtina Dr., Medical Doctor
ekaterina.laukhtina@meduniwien.ac.at
+43 (0)1 40400-26315
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2028-11
Participants
Target number of participants: 50
Treatments
Experimental: Patients with urothelial carcinoma treated with clofarabine
Related Therapeutic Areas
Sponsors
Leads: Ekaterina Laukhtina

This content was sourced from clinicaltrials.gov

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