A Phase I/II Randomized Study Evaluating if the study drug Alpha1H is effective and safe in comparison to placebo in adult patients with bladder cancer before planned surgery to remove tumour

Phase 1

• Conditions: on-muscle invasive bladder cancer awaiting transurethral surgery; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004269-14-CZ
• Lead Sponsor: Hamlet Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-27
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Signed and dated informed consent.

Patient with non-muscle invasive papillary bladder cancer (NMIBC) based on cystoscopy appearance, on the waiting list for TURB.

Male and female subjects, 18 years or older.

Negative pregnancy test in women of childbearing potential.

Appropriate methods of contraception in women of childbearing potential during study.

Patients should be able to keep the content of the bladder for at least one hour.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patient with a previous history of muscle invasive bladder cancer.

Patient with a history of NMIBC with an interval shorter than 6 months after previous TURB.

Previous intravesical BCG immunotherapy in the last 12 months.

Previous intravesical chemotherapy in the last 12 months.

Participants with any other cancer diagnosis within the last 5 years (except of skin basaliomas).

Acute urinary tract infection

Participants with prior radiotherapy or systemic chemotherapy.

Participants receiving any other investigational agent or non-marketed product one month prior to Visit 1 and during the trial.

Any concurrent illness that may render a participant ineligible or limit compliance with study requirements.

Previously enrolled in this trial.

Study & Design

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