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Completed

NCT Number: NCT00286806

A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer

This is an open-label, multicenter Phase I/II study to evaluate the safety and efficacy of single-agent AT-101 in men with hormone-refractory prostate cancer.

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Key information

Conditions

Hormone Refractory Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Greenbrae, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rising PSA, as defined by increasing levels on at least two consecutive assessments
  • ECOG performance status 0 or 1
  • Adequate hematologic function
  • Adequate liver and renal function
  • Able to swallow and retain oral medication.

Exclusion criteria

  • Received prior chemotherapy for HRPC.
  • Concurrent therapy for the treatment of prostate cancer.
  • Clinical signs or symptoms of CNS metastases
  • Requirement for corticosteroid treatment, with the exception of topical corticosteroids or inhaled corticosteroids for reactive airway disease.
  • Active secondary malignancy or history of other malignancy within the last 5 years.
  • Failure to recover from toxicities related to prior therapy.
  • Uncontrolled concurrent illness.

Treatment and study plan

AT-101

Drug

Primary outcomes

  1. Number of participants with adverse events.

Secondary outcomes

  1. Complete or partial remission of disease

Sponsors and collaborators

Lead sponsor

Ascenta Therapeutics

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase I/II Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer (HRPC) and Rising Prostate Specific Antigen (PSA) Levels Who Have Not Received Prior Chemotherapy

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Feb 6, 2006
Registry last updated
Aug 24, 2010

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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