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OpenTrials
Completed

NCT Number: NCT00900614

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

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.

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Key information

Conditions

Hematologic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Hematologic Diseases Hemic and Lymphatic Diseases Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Section of Haematology and Coagulation, Sahlgrenska University Hospital, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APR-246

Drug

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

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.

    Time frame: 21 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Aprea Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 13, 2009
Registry last updated
Jul 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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