Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.

Aplidin (plitidepsin)

Celestia Higano, M.D.

Maha Hussain, M.D.

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.

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.

A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer

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..

Patients with an objective tumor response (complete response \[CR\] or partial response \[PR\]) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST), See Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, et al. New Guidelines to Evaluate the Response to Treatment in Solid Tumors. J Natl Cancer Inst 2000; 92:205-16.

To assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after 2 previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy.

PFS defined as time from the first day of study treatment to the day of a negative outcome (progression according to RECIST (Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, et al. New Guidelines to Evaluate the Response to Treatment in Solid Tumors. J Natl Cancer Inst 2000; 92:205-16) or death) or last contact. If any patient is lost to follow up before disease progression, the PFS will be censored at the date of the last tumor assessment. If there are no tumor assessments the patient will be censored at the first drug administration date.

To assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after two previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy.

Survival is measured from the first day of study treatment to death or day of their last follow-up

To assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after two previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy.

Expressed as a change in pain intensity according to the pain intensity score on the 100 mm VAS (Visual Analogue Scale) and/or change in analgesic (morphine-equivalent mg) requirements after a pain stabilization period of 2-7 days

Visual Analogue Scale (VAS), expressed in the pain intensity score on the 100 mm VAS scale (0=least possible pain to 100=worst possible pain)

To assess the antitumor activity of plitidepsin given intravenously over 3-hours every two weeks in patients with castrate metastatic adenocarcinoma of the prostate that have relapsed or progressed after two previous lines of systemic therapy, considering biological agents or chemotherapy as systemic therapy and taking into account that patients must have received prior docetaxel-based chemotherapy.

It was calculated as (nadir value-baseline value)/(nadir date-baseline date). Modifications in the slope of PSA changes before and after the start of treatment with Aplidin will also be explored.

PharmaMar

Aplidin (Plitidepsin)

Aplidin (plitidepsin): Aplidin® administered at a starting dose of 5 mg/m2, as a 3-hours intravenous infusion, every 2 weeks.

Spots Global Cancer Trial Database for A Study of Aplidin ( Plitidepsin) in Subjects With Advanced Prostate Cancer

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