Clinical trial NCT01732549: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Castrate Resistant Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Time to Radiological Progression Free Survival [PFS]
timeFrame: Every 8 weeks until disease progression documentation (approximately up to 2.5 years)
Secondary outcomes:
measure: Overall Survival Based on Number of Subjects Who Died
timeFrame: Every 3 months after study treatment stop until death (approximately up to 2.5 years)
measure: Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)
timeFrame: Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)
measure: Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death
timeFrame: Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)
measure: Time to Further Anticancer Treatment for Prostate Cancer
timeFrame: Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)
measure: Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P)
timeFrame: Up to End of Study visit (approximately up to 2.5 years)
measure: Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score
timeFrame: Baseline and End-of-study Visit (approximately up to 2.5 years)
measure: Safety Profile of Tasquinimod
timeFrame: At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
city: Roeselare
country: Belgium
city: Praha
country: Czechia
state: Hradčany
city: Praha
country: Czechia
state: Libeň
city: Brno
country: Czechia
city: Olomouc
country: Czechia
city: Prague 2
country: Czechia
city: Aalborg
country: Denmark
city: Aarhus
country: Denmark
city: Herlev
country: Denmark
city: København
country: Denmark
city: Angers
country: France
city: Bordeaux
country: France
city: Clermont Ferrand
country: France
city: Dijon
country: France
city: Lille
country: France
city: Lyon
country: France
facility: Besancon
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Paris
country: France
city: St Herblain
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Aachen
country: Germany
city: Essen
country: Germany
city: München
country: Germany
city: Nürtingen
country: Germany
city: Tübingen
country: Germany
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Kórház
city: Budapest
country: Hungary
facility: Országos Onkológia Intézet
city: Budapest
country: Hungary
facility: Uzsoki utcai Kórház
city: Genova
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Rozzano
country: Italy
city: Torino
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Olsztyn
country: Poland
city: Wroclaw
country: Poland
facility: Urology and Urological Oncology Department and Clinic
city: Wroclaw
country: Poland
facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu
city: Barcelona
country: Spain
facility: Hospital Clinic Vllarroel
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Valle de Hebrón
city: Elche
country: Spain
city: Sabadell
country: Spain
city: Valencia
country: Spain
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
facility: Guy's & St Thomas NHS Foundation
city: London
country: United Kingdom
facility: The Royal Marsden NHS Trust
city: London
country: United Kingdom
facility: University College Hospitals London
city: Sutton
country: United Kingdom
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: Fizazi K, Ulys A, Sengelov L, Moe M, Ladoire S, Thiery-Vuillemin A, Flechon A, Guida A, Bellmunt J, Climent MA, Chowdhury S, Dumez H, Matouskova M, Penel N, Liutkauskiene S, Stachurski L, Sternberg CN, Baton F, Germann N, Daugaard G. A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy. Ann Oncol. 2017 Nov 1;28(11):2741-2746. doi: 10.1093/annonc/mdx487.