search
Back to results

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

Primary Purpose

Hematologic Neoplasms, Prostatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
APR-246
Sponsored by
Aprea Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Neoplasms focused on measuring Hematologic malignancy, Prostate carcinoma, Hematologic cancer, Prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Section of Haematology and Coagulation, Sahlgrenska University Hospital
  • Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
  • Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
  • Department of Haematology, Akademiska Hospital
  • Department of Hematology, University Hospital
  • Urology clinic, University Hospital

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
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.

Full Information

First Posted
May 11, 2009
Last Updated
July 29, 2019
Sponsor
Aprea Therapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT00900614
Brief Title
Safety Study of APR-246 in Patients With Refractory Hematologic Cancer or Prostate Cancer
Official Title
An Open-label Phase I Dose Escalating Study of APR-246 for Infusion in Patients With Refractory Hematologic Malignancies or Prostate Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aprea Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms, Prostatic Neoplasms
Keywords
Hematologic malignancy, Prostate carcinoma, Hematologic cancer, Prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
APR-246
Intervention Description
Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: Acute myeloid leukemia. Acute lymphoid leukemia. Chronic lymphocytic leukemia. Chronic myeloid leukemia. Chronic myelomonocytic leukemia. Multiple myeloma. Non Hodgkin's lymphoma. Hodgkin's lymphoma. Myelodysplastic syndrome. Myelofibrosis. Hormone refractory, metastatic prostate carcinoma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sören Lehmann, MD, PhD
Organizational Affiliation
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Section of Haematology and Coagulation, Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge
City
Stockholm
ZIP/Postal Code
SE 141 86
Country
Sweden
Facility Name
Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Department of Haematology, Akademiska Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Department of Hematology, University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Urology clinic, University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs