Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer

July 29, 2019 updated by: Aprea Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41345
        • Section of Haematology and Coagulation, Sahlgrenska University Hospital
      • Stockholm, Sweden, SE 141 86
        • Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
      • Uppsala, Sweden, 75185
        • Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
      • Uppsala, Sweden, 75185
        • Department of Haematology, Akademiska Hospital
      • Örebro, Sweden, 70185
        • Department of Hematology, University Hospital
      • Örebro, Sweden, 70185
        • Urology clinic, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-Limiting Toxicity (DLT) is reached and HFD is defined accordingly, OR the dose, which is expected to result in maximum plasma concentration close to, but not exceeding 35 μg/ml in any single patient without showing signs of DLT.
Time Frame: 21 days
21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
Time Frame: continuously during 21 days
continuously during 21 days
Determination of the PK profile for up to 22 hours after the last APR-246 infusion. Cmax (maximal plasma concentration), AUC (area under the curve), t1/2 (half-life) and clearance will be determined.
Time Frame: continuously, during 21 days
continuously, during 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aprea Therapeutics

Investigators

  • Principal Investigator: Sören Lehmann, MD, PhD, Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Actual)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR-246-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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