Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Durvalumab

Phase 1

• Conditions: Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract; MedDRA version: 21.1Level: PTClassification code 10061272Term: Malignant urinary tract neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-003031-29-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-07
• Last Update Posted: 25 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

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

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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified