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

NCT00780975 | Terminated Phase 2 Results

• 1 other identifier: APL-B-011-02
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Aplidin; Plitidepsin; Prostate; Cancer

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients With a ≥ 50% Prostate-specific Antigen (PSA) Decline Post-therapy

  All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first

Secondary Outcomes (5)

• Objective Tumor Response According to RECIST

  All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first

• Progression Free Survival (PFS)

  All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first

• Overall Survival (OS)

  All patients were followed up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment visit of the last patient, whichever occured first

• Pain Improvement Rate

  2-7 days for the pain stabilization required at baseline to ensure that baseline values are stable and reliable. The follow-up period was up to progressive disease, start of a new anti-cancer therapy, death or one year after the last treatment

• PSA Slope Between Baseline PSA Value and Nadir After the Start of Treatment

  From baseline until progression or initiation of another anticancer therapy, death or one year after the last treatment visit of the last patient, whichever occurred first.

Study Arms (1)

Arm 1

EXPERIMENTAL

Aplidin (Plitidepsin)

Drug: Aplidin (plitidepsin)

Interventions

Aplidin (plitidepsin) DRUG

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Confirmed pathological diagnosis.
• Metastatic disease (radiologically documented).
• All patients with chemical castration must have a serum testosterone level below 50 ng/ml. There is no need to document a serum testosterone in patients having a prior surgical castration2.
• Baseline PSA \> 5 ng/ml (according to the recommendations from the Prostate-Specific Antigen Working Group2).
• Androgen-independent progressive disease, as defined by detectable, rising PSA in two consecutive measurements at least one week apart:
• If PSA responded to a prior therapy, progression occurs when the PSA is 50% above the nadir level.
• If PSA did not respond to a prior therapy, progression occurs when the PSA increases by 25% or more above pretreatment levels.
• In both cases, the increase in absolute value PSA level must be at least 5 ng/ml, and must be confirmed by a second measurement a minimum of 1 week later.
• Patients must have received prior docetaxel-based chemotherapy.
• 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.

You may not qualify if:

• 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:
• weeks after the last dose of a nitroso-urea or high dose chemotherapy
• weeks after the last dose of other chemotherapies or biological agents
• weeks after the end of treatment with extensive external beam radiation (more than 25% of bone marrow distribution) or radionuclide therapy.
• weeks after the end of treatment with palliative radiation involving less than 25% of bone marrow reserves.
• weeks for major prior surgery
• 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:
• Non-melanoma skin cancer. 8.2 Any other cancer curatively treated with no evidence of disease for at least 10 years.

Sponsors & Collaborators

• PharmaMar: lead

Study Sites (2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0473, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

plitidepsin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Clinical Development Department of PharmaMar´s Oncology,Business Unit.,
• Organization: Pharma Mar, S.A.

clinicaltrials@pharmamar.com

+34 918466000

Study Officials

• Celestia Higano, M.D.

  Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

• Maha Hussain, M.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: February 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-11

Locations

US (2)