Completed

Study of ILX651 in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel

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What is being tested

ILX651

Drug
Who is being recruted

Hormone-refractory Prostate Cancer

Over 19 Years
+25 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional

See protocol details

Summary

Principal SponsorGenzyme, a Sanofi Company
Last updated: March 5, 2015
Sourced from a government-validated database.Claim as a partner

This is a Phase II, non-randomized, open label study of ILX651 in patients with hormone-refractory prostate cancer previously treated with docetaxel. Approximately 40 patients will be enrolled in this study that is expected to last 24 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days every 21 days. The primary objective of this study is to determine the PSA response rate. The secondary objectives are to determine response of measurable disease, duration of response, time to PSA progression, time to treatment failure, survival, safety and tolerability, and pharmacokinetic profile of ILX651.

Official TitleA Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Every 21 Days in Patients With Hormone-Refractory Prostate Cancer Previously Treated With Docetaxel 
Principal SponsorGenzyme, a Sanofi Company
Last updated: March 5, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Over 19 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hormone-refractory Prostate Cancer
Criteria
13 inclusion criteria required to participate
Patient has hormone-refractory prostate cancer (HRPC) as evidenced by PSA progression or progression of measurable disease
Patient has greater than 25% increase in 2 consecutive tests in which the first increase in PSA should occur a minimum of 1 week apart
Patients on androgen deprivation treatment and will continue on androgen deprivation treatment during study participation except for patients who are post orchiectomy
Patient has evidence of metastatic disease by positive bone scan or evidence of progressive metastatic disease by CT scan

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12 exclusion criteria prevent from participating
Prior treatment with 2 or more prior chemotherapy regimens
Concurrent treatment with an estrogen-containing agent including diethylstilbestrol (DES)
Prior flutamide (Eulexin) within past 4 weeks, prior bicalutamide (Casodex) within past 6 weeks, or prior nilutamide (Nilandron) within past 6 weeks
Prior strontium or samarium or other radioisotope therapy

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 12 locations
Suspended
Arizona Clinical Research CenterTucson, United StatesSee the location
Suspended
Kansas City Cancer CentersLenexa, United States
Suspended
Kansas City Cancer CentersOverland Park, United States
Suspended
Kansas City Cancer Centers- CentralKansas City, United States
Completed12 Study Centers