Completed

An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2009
See protocol details

Summary

Principal SponsorAprea Therapeutics
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2009

Actual date on which the first participant was enrolled.

The purpose of this study is to determine the highest feasible dose (HFD) of intravenous (IV) APR-246 when given to patients with refractory hematologic malignancies or prostate carcinoma.

Official TitleAn Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
NCT00900614
Principal SponsorAprea Therapeutics
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleHematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsHematologic NeoplasmsMale Urogenital Diseases

Criteria

Summary criteria for participant selection: Inclusion Criteria: * Male or female ≥ 18 years of age. * Any below mentioned advanced disease, which is not eligible for other therapies. The diagnosis should have been confirmed either histologically or cytologically: 1. Acute myeloid leukemia. 2. Acute lymphoid leukemia. 3. Chronic lymphocytic leukemia. 4. Chronic myeloid leukemia. 5. Chronic myelomonocytic leukemia. 6. Multiple myeloma. 7. Non Hodgkin's lymphoma. 8. Hodgkin's lymphoma. 9. Myelodysplastic syndrome. 10. Myelofibrosis. 11. Hormone refractory, metastatic prostate carcinoma.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Section of Haematology and Coagulation, Sahlgrenska University Hospital

Gothenburg, SwedenOpen Section of Haematology and Coagulation, Sahlgrenska University Hospital in Google Maps
Suspended

Department of Hematology, University Hospital

Örebro, Sweden
Suspended

Urology clinic, University Hospital

Örebro, Sweden
Suspended

Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge

Stockholm, Sweden
Completed6 Study Centers