A Proof of Concept Study of Maintenance Therapy With Tasquinimod in Patients With Metastatic Castrate-resistant Prostate Cancer Who Are Not Progressing After a First Line Docetaxel Based Chemotherapy

This study is currently recruiting participants.
Verified March 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01732549
First received: October 24, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.


Condition Intervention Phase
Metastatic Castrate Resistant Prostate Cancer
Drug: Tasquinimod
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Time to radiological progression free survival [PFS] [ Time Frame: Every 8 weeks, up to 3.5 years ] [ Designated as safety issue: No ]
    The time from the date of randomisation to the date of radiological progression or death due to any cause.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Every 8 weeks, up to 3.5 years ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomisation to death due to any cause

  • Time to progression free survival [PFS] on next-line therapy (PFS 2) [ Time Frame: Every 8 weeks, up to 3.5 years ] [ Designated as safety issue: No ]
    The time from the date of randomisation to the date of radiological progression free survival [PFS] on next-line therapy (PFS 2) or death due to any cause.

  • Symptomatic PFS [ Time Frame: Every 8 weeks, up to 3.5 years ] [ Designated as safety issue: No ]
    Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first (symptomatic progression as assessed by Brief Pain Inventory [BPI] and analgesic use)

  • Safety profile of tasquinimod [ Time Frame: Every 8 weeks, up to 3.5 years ] [ Designated as safety issue: Yes ]
    Number of subjects reporting adverse events


Estimated Enrollment: 140
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tasquinimod
1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg or 1 mg per day) until disease progression.
Drug: Tasquinimod
A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively.
Placebo Comparator: Placebo
1 capsule daily, taken orally with water and food until disease progression
Drug: Placebo
Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented prostate cancer with evidence of metastatic disease on radiological evaluation, with or without symptoms (defined according to the BPI scale, with use of analgesics or narcotics)
  • Has received a first line docetaxel based chemotherapy (as a monotherapy) every 3 weeks schedule of administration with corticosteroids for a minimum of 6 cycles with a cumulative dose ≥360 mg/m2. Any combination with investigational or non investigational agent is prohibited
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Docetaxel-related adverse effects must have been resolved to NCI-CTCAE v4.03 (Common Toxicity Criteria for Adverse Effects) Grade ≤1. Chemotherapy-induced alopecia and Grade 2 peripheral neuropathy are allowed
  • No progressive disease at the end of docetaxel treatment defined according to RECIST criteria, no new lesion(s) assessed by bone scan and no elevated prostate specific antigen (PSA) for the three last tests with PSA3≤PSA2≤PSA1. The time between each PSA test should be preferably at least 14 days, however, a minimum of 7 days is acceptable.

Note: PSA value can be rounded to the nearest whole number if PSA>10 ng/mL. If the PSA3 value is above the PSA2, a fourth PSA test will be performed. The PSA4 value should be below or equal to PSA2

  • Last dose of docetaxel administered between 21 and 42 days before randomisation
  • Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L)

Exclusion Criteria:

  • Has concurrent use of other anticancer agents or treatments, with the following exceptions: ongoing treatment with luteinising hormone-releasing hormone agonists or antagonists, denosumab or bisphosphonate (e.g., zoledronic acid) is permitted if started ≥4 weeks prior to Screening. Ongoing treatment should be kept at a stable dose regimen
  • Has ongoing treatment with warfarin
  • Had prior radiation therapy since starting docetaxel. Exceptions may be made for palliative non-myelosuppressive radiation therapy administered more than 2 weeks prior to randomisation
  • Had prior strontium, samarium or radium therapy or prior treatment with tasquinimod, or any agents with antiangiogenic properties
  • Has ongoing treatment with corticosteroids at >10 mg/day prednisolone equivalent
  • Has prostate cancer pain that warrants the initiation of radiotherapy or chemotherapy
  • Has known brain or epidural metastases. Patients with previous medullary cord compression without any neurological deficit could be included
  • Has a history of other malignancies, except adequately treated non-melanoma skin cancer or other solid tumours curatively treated, without evidence of disease for >5 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732549

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 58 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Nathalie Germann, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01732549     History of Changes
Other Study ID Numbers: 8-55-58102-002
Study First Received: October 24, 2012
Last Updated: March 27, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Lithuania: State Medicine Control Agency - Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014