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

NCT ID: NCT01732549

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-05-31

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.

Conditions

Metastatic Castrate Resistant Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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 or toxicity or patient's willingness to stop.

Group Type: EXPERIMENTAL

Tasquinimod

Intervention Type: DRUG

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

1 capsule daily, taken orally with water and food until disease progression or toxicity or patient's willingness to stop.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

AZ Maria Middelares

Ghent, , Belgium

UZ Gent

Ghent, , Belgium

Leuven, , Belgium

Roeselare, , Belgium

Prague, Hradčany, Czechia

Prague, Libeň, Czechia

Brno, , Czechia

Olomouc, , Czechia

Prague, , Czechia

Aalborg, , Denmark

Aarhus, , Denmark

Copenhagen, , Denmark

Herlev, , Denmark

Angers, , France

Bordeaux, , France

Clermont-Ferrand, , France

Dijon, , France

Lille, , France

Besancon

Lyon, , France

Centre Leon Berard

Lyon, , France

Hopital Edouard Herriot

Lyon, , France

Paris, , France

Saint-Herblain, , France

Toulouse, , France

Villejuif, , France

Aachen, , Germany

Essen, , Germany

München, , Germany

Nürtingen, , Germany

Tübingen, , Germany

Bajcsy-Zsilinszky Kórház

Budapest, , Hungary

Országos Onkológia Intézet

Budapest, , Hungary

Uzsoki utcai Kórház

Budapest, , Hungary

Genova, , Italy

Milan, , Italy

Modena, , Italy

Pavia, , Italy

Roma, , Italy

Rozzano, , Italy

Torino, , Italy

Kaunas, , Lithuania

Vilnius, , Lithuania

Gdansk, , Poland

Gdynia, , Poland

Olsztyn, , Poland

Urology and Urological Oncology Department and Clinic

Wroclaw, , Poland

Wojewódzki Szpital Specjalistyczny we Wrocławiu

Wroclaw, , Poland

Hospital Clinic Vllarroel

Barcelona, , Spain

Hospital del Mar

Barcelona, , Spain

Hospital Valle de Hebrón

Barcelona, , Spain

Elche, , Spain

Sabadell, , Spain

Valencia, , Spain

Leeds, , United Kingdom

Guy's & St Thomas NHS Foundation

London, , United Kingdom

The Royal Marsden NHS Trust

London, , United Kingdom

University College Hospitals London

London, , United Kingdom

Sutton, , United Kingdom

Countries

Belgium; Czechia; Denmark; France; Germany; Hungary; Italy; Lithuania; Poland; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29059273 (View on PubMed)

Other Identifiers

2012-001038-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8-55-58102-002

Identifier Type: -

Identifier Source: org_study_id