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A First-in-Human Study of alpha1H in Patients With Non-muscle Invasive Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03560479
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Information provided by (Responsible Party):
Hamlet Pharma AB

Brief Summary:

This study evaluates the tolerability and preliminary anti-tumour effect of alpha1H in adults with non-muscle invasive bladder cancer, who are awaiting transurethral surgery.

Half of the subjects will receive treatment with alpha1H and the other half will receive placebo. The treatment is given on 6 occasions during a period of 22 days. The total study duration is 8 - 12 weeks including follow-up.

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Drug: alpha1H Other: placebo Phase 1 Phase 2

Detailed Description:

Protein-lipid complexes represent a new type of tumouricidal biologicals, with broad effects against cancers of different origins. The investigational product alpha1H is a synthetic peptide, corresponding to the alpha1 domain of α-lactalbumin, in complex with oleic acid. Alpha1H is a further development product of HAMLET, a complex between human alpha-lactalbumin and oleic acid, which has shown broad anti-tumor activity with a high degree of selectivity.

This study is a combined phase 1/2, placebo controlled, double blind study in subjects with non-muscle invasive bladder cancer awaiting transurethral resection of bladder (TURB). The study is randomized 1/1 and the subjects will receive intravesical instillation of either alpha1H or placebo on 6 occasions during a period of 22 days (on days 1, 3, 5, 8, 15 and 22).

Cell shedding is quantified and characterized at each treatment occasion. The bladder tumors are characterized prior treatment and prior to the scheduled surgery. Remaining tumors will be removed by TURB (according to European Association of Urology (EAU) Guidelines recommendations) and tissues will be obtained for analyses.

A follow-up Visit will take place 30 days after the last administration of study treatment.

The total study duration is 8 - 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized to receive intravesical instillations of either alpha1H (fixed dose) or placebo. The randomization ratio is 1:1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Phase I/II Study Evaluating the Safety and Efficacy of alpha1H in Adult Patients With Non-muscle Invasive Bladder Cancer Awaiting Transurethral Surgery
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: alpha1H
alpha1H (7.4 mg/mL), solution for instillation, 30 mL
Drug: alpha1H
Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

Placebo Comparator: placebo
Placebo, 0.9% NaCl (sodium chloride), 30 mL
Other: placebo
Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)

Primary Outcome Measures :
  1. Safety as Adverse Events Profile [ Time Frame: From signing of informed consent (Day 1) and until End of Study, (Day 52) ]
    Incidence of adverse events and classification in terms of severity, causality and outcome

  2. Efficacy as Cell Shedding [ Time Frame: Days 1 to 22 ]
    Change in cell shedding into urine (number of epithelial cells per mL of urine).

  3. Change from baseline in characteristics of papillary tumors [ Time Frame: Prior to treatment (Baseline) and on Day 30, in connection with scheduled surgery. ]
    The bladder tumors will be characterised by in vivo imaging during examination by cystoscopy.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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 Bacillus Calmette-Guerin (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03560479

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Contact: Catharina Svanborg, Prof. +4640122505
Contact: Mats Persson, PhD +4640122500

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Motol University Hospital Recruiting
Prague, Czechia
Contact: Marek Babjuk, MD, Prof         
Sponsors and Collaborators
Hamlet Pharma AB
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Principal Investigator: Marek Babjuk, MD, Prof. Motol University Hospital

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Responsible Party: Hamlet Pharma AB Identifier: NCT03560479     History of Changes
Other Study ID Numbers: HP002-001
2016-004269-14 ( EudraCT Number )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hamlet Pharma AB:
First-in human
Phase 1
Phase 2
Bladder cancer
Clinical trial
Non-muscle invasive

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases