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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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Metastatic Castrate Resistant Prostate Cancer

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Trial Information

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


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 of 75 mg/m² (as starting dose)
every 3 weeks schedule of administration with corticosteroids for a minimum of 6
cycles. 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
Response Evaluation Criteria in Solid Tumors (RECIST) criteria, no new lesion(s)
assessed by bone scan and no elevated prostatic specific antigen (PSA) for the three
last tests (with the first two PSA values above or equal to the third PSA value). The
time between each PSA test should be preferably at least 14 days, however a minimum
of 7 days is acceptable. The third value will be used for study selection

- 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

Type of Study:

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

Outcome Measure:

Time to radiological progression free survival [PFS]

Outcome Description:

The time from the date of randomisation to the date of radiological progression or death due to any cause.

Outcome Time Frame:

Every 8 weeks, up to 3.5 years

Safety Issue:

No

Principal Investigator

Frederique Baton, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

8-55-58102-002

NCT ID:

NCT01732549

Start Date:

January 2013

Completion Date:

February 2016

Related Keywords:

  • Metastatic Castrate Resistant Prostate Cancer
  • Prostatic Neoplasms

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