Trials Sponsors Conditions Drugs Pricing

Conditions

Hematologic Neoplasms Prostatic Neoplasms

Keywords

Hematologic malignancyProstate carcinomaHematologic cancerProstate cancer

Outcome Measures

Primary Outcomes (1)

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.
21 days

Secondary Outcomes (2)

Determination of the toxicity and safety profile of APR-246 based on safety parameters from the entire study period.
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.
continuously, during 21 days

Interventions

APR-246Drug

Intravenous infusion. Dose escalating. Dosing will be conducted with three patients at each dose level.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:

Sponsors & Collaborators

Aprea Therapeutics
Industrylead

Study Sites (6)

Section of Haematology and Coagulation, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Department of Hematology, University Hospital

Örebro, 70185, Sweden

Urology clinic, University Hospital

Örebro, 70185, Sweden

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

Stockholm, SE 141 86, Sweden

Clinical Research and Development Unit, Department of Oncology, Akademiska Hospital

Uppsala, 75185, Sweden

Department of Haematology, Akademiska Hospital

Uppsala, 75185, Sweden

MeSH Terms

Conditions

Hematologic NeoplasmsProstatic Neoplasms

Interventions

eprenetapopt

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

Sören Lehmann, MD, PhD
Hematology Centre, M54, Karolinska Institute, Karolinska University Hospital, Huddinge, SE-141 86, Stockholm, Sweden
PRINCIPAL INVESTIGATOR

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

May 2009

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations