Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006417

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006417
  •   2014/11/04
  •   2012/10/24
  •   no
  •   [---]*
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Secondary IDs

  •   NCT01732549  (ClinicalTrials.gov)
  •   8-55-58102-002  (Ipsen)
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Health Condition or Problem studied

  •   Metastatic Castrate Resistant Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Tasquinimod
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Time to radiological progression free survival [PFS]; time frame: Every 8 weeks, up to 3.5 years; The time from the date of randomisation to the date of radiological progression or death due to any cause.

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Secondary Outcome

- Overall survival; time frame: Every 8 weeks, up to 3.5 years; 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; 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; 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; Number of subjects reporting adverse events

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Countries of Recruitment

  •   Belgium
  •   Czech Republic
  •   Denmark
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Lithuania
  •   Poland
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

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  •   2013/01/31
  •   140
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional 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)

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Ipsen
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    •   [---]*
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    • Ipsen
    • Nathalie Germann, MD 
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    •   [---]*
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    • Ipsen
    • Nathalie Germann, MD 
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    •   [---]*
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2015/05/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.