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Sponsored by: |
PharmaMar |
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Information provided by: | PharmaMar |
ClinicalTrials.gov Identifier: | NCT00780975 |
This is a study to test the safety and efficacy of an investigational chemotherapy agent in patients with advanced prostate cancer. Subjects who meet all entry criteria and have signed the informed consent will be enrolled in the study. Participants will be required to attend regular clinic visits to receive study medication and have their status monitored. A detailed explanation can be provided by the investigator conducting the study.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: Aplidin (plitidepsin) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Open-Label, Clinical and Pharmacokinetic Study of Aplidin® as a 3-Hour IV Infusion Every 2 Weeks, in Relapsing or Refractory Patients With Androgen-Independent Prostate Adenocarcinoma.. |
Enrollment: | 8 |
Study Start Date: | February 2005 |
Study Completion Date: | March 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
Aplidin (Plitidepsin)
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Drug: Aplidin (plitidepsin)
Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
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Prostate cancer is the most common non-cutaneous cancer diagnosed in men in the United States. The majority of deaths occur in men with androgen-independent prostate cancer [AIPC]. Although 80% of men with advanced cancer will initially respond to androgen ablation with disease regression or stabilization, their malignancies become resistant to such therapy.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men with castrate metastatic adenocarcinoma of the prostate, with the following characteristics:
Androgen-independent progressive disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart:
Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study):
Exclusion Criteria:
Wash-out periods less than:
History of another neoplastic disease. The exceptions are:
8.1 Non-melanoma skin cancer. 8.2 Any other cancer curatively treated with no evidence of disease for at least 10 years.
Other relevant diseases or adverse clinical conditions:
Abnormal ECG as detailed below:
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0473 | |
United States, Washington | |
Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Celestia Higano, M.D. | Seattle Cancer Care Alliance |
Principal Investigator: | Maha Hussain, M.D. | University of Michigan Cancer Center |
Responsible Party: | PharmaMar USA Inc. Av de los Reyes, 1 28770 Colmenar Viejo (Madrid) Spain ( PharmaMar USA Inc. ) |
Study ID Numbers: | APL-B-011-02 |
Study First Received: | October 27, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00780975 |
Health Authority: | United States: Food and Drug Administration |
Aplidin Plitidepsin Prostate Cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site |