A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer
This study has been terminated.
Information provided by (Responsible Party):
First received: October 27, 2008
Last updated: October 27, 2014
Last verified: February 2010
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.
Drug: Aplidin (plitidepsin)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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..
Primary Outcome Measures:
- Determination of maximum tolerated dose [ Time Frame: Along the study ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
Experimental: Arm 1
Drug: Aplidin (plitidepsin)
Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.
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:
|Accepts Healthy Volunteers:
- Written informed consent before starting any study-specific procedure. If any patient is unable to give consent, it may be obtained from the patient's legal representative if in accordance with local laws and regulations.
Men with castrate metastatic adenocarcinoma of the prostate, with the following characteristics:
- Recovery from any toxicity derived from previous treatments. The presence of alopecia and NCI-CTC grade < 2 sensitive peripheral neuropathy is allowed.
- Age > 18 years.
- Performance status (ECOG) < 2.
- Life expectancy > 3 months.
Adequate renal, hepatic, and bone marrow function (assessed < 14 days before inclusion in the study):
- Neutrophil count ³ 1.5 x 109/L.
- Platelet count ³ 100 x 109/L. Hemoglobin > 9 g/dl.
- Creatinine clearance ³ 40 ml/min (calculated from the Cockcroft and Gault formula), see Appendix 3.
- Serum bilirubin * 1.5 mg/dl.
- AST, ALT < 2.5 x ULN (< 5 x ULN in case of liver metastasis).
- Albumin > 25 g/L.
- Left ventricular ejection fraction within normal limits
- Prior therapy with Aplidin®.
- Concomitant therapy with any anti-tumor agent, including glucocorticoids at a daily dose greater than 10 mg prednisone or equivalent, except when they were indicated for symptom control, provided that disease progression was documented while on steroids.
- Small cell carcinoma of the prostate.
- More than two previous lines of systemic therapy for patient's castrate metastatic disease, considering biological agents or chemotherapy as systemic therapy.
- Patients with progressive measurable disease but without increased PSA value (according to the consensus recommendations) will not be considered eligible.
Wash-out periods less than:
- 6 weeks after the last dose of a nitroso-urea or high dose chemotherapy
- 4 weeks after the last dose of other chemotherapies or biological agents
- 6 weeks after the end of treatment with extensive external beam radiation (more than 25% of bone marrow distribution) or radionuclide therapy.
- 4 weeks after the end of treatment with palliative radiation involving less than 25% of bone marrow reserves.
- 4 weeks for major prior surgery
- 30 days after receiving any other investigational product
- Men of reproductive potential who are not using effective contraceptive methods, considering complete abstinence from intercourse throughout the treatment with the study drug and for at least 6 months after completion or premature discontinuation from the study as an effective contraceptive method, to be sure that the patient's female partner does not become pregnant.
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.
- Known symptomatic cerebral or leptomeningeal involvement.
Other relevant diseases or adverse clinical conditions:
- Known hypersensitivity to Aplidin®, mannitol, cremophor EL, or ethanol.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780975
|University of Michigan Comprehensive Cancer Center
|Ann Arbor, Michigan, United States, 48109-0473 |
|Seattle Cancer Care Alliance
|Seattle, Washington, United States, 98109 |
||Celestia Higano, M.D.
||Seattle Cancer Care Alliance
||Maha Hussain, M.D.
||University of Michigan Cancer Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 27, 2008
||October 27, 2014
||United States: Food and Drug Administration
Keywords provided by PharmaMar:
ClinicalTrials.gov processed this record on March 26, 2015