Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract MedDRA version: 21.1 Level: PT Classification code 10061272 Term: Malignant urinary tract neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Durvalumab
Product Code: MEDI4736
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Durvalumab
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Conce
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of signed and dated, written ICF. 2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study’s protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: Core Protocol exclusion criteria: 1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study. 2. Currently receiving treatment with any prohibited medication(s). 3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 4. Permanent discontinuation from the parent study due to toxicity or disease progression. 5. Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation. Additional exclusion criteria for the ROSY-D sub-study: 6. Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies). 7. Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy. 8. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of = 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide continuous study treatment to patients who continue to benefit at the end of a clinical study, while monitoring safety and tolerability.;Secondary Objective: Not applicable;Primary end point(s): SAEs reported until 90 days after the last dose of study treatment.;Timepoint(s) of evaluation of this end point: Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Canada, Czech Republic, France, Germany, Hungary, Italy, Korea, Republic of, Romania, Spain, United Kingdom, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed