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Metastatic Castrate Resistant Prostate CancerPhase 2NCT01732549

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

A Phase 2 study testing Tasquinimod in people with Metastatic Castrate Resistant Prostate Cancer, run by Ipsen at 58 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Tasquinimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
58 sitesin 11 countries
Study dates
Jan 2013to May 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

58 sites in 11 countries.

58 sites in 11 countries

France12 sites

  • Study site

    Angers

  • Study site

    Bordeaux

  • Study site

    Clermont-Ferrand

  • Study site

    Dijon

  • Study site

    Lille

  • Besancon

    Lyon

  • Centre Leon Berard

    Lyon

  • Hopital Edouard Herriot

    Lyon

  • Study site

    Paris

  • Study site

    Saint-Herblain

  • Study site

    Toulouse

  • Study site

    Villejuif

Other trials in France

Italy7 sites

  • Study site

    Genova

  • Study site

    Milan

  • Study site

    Modena

  • Study site

    Pavia

  • Study site

    Roma

  • Study site

    Rozzano

  • Study site

    Torino

Other trials in Italy

Spain6 sites

  • Hospital Clinic Vllarroel

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Valle de Hebrón

    Barcelona

  • Study site

    Elche

  • Study site

    Sabadell

  • Study site

    Valencia

Other trials in Spain

Czechia5 sites

  • Study site

    Brno

  • Study site

    Olomouc

  • Study site

    Prague, Hradčany

  • Study site

    Prague, Libeň

  • Study site

    Prague

Other trials in Czechia

Germany5 sites

  • Study site

    Aachen

  • Study site

    Essen

  • Study site

    München

  • Study site

    Nürtingen

  • Study site

    Tübingen

Other trials in Germany

Poland5 sites

  • Study site

    Gdansk

  • Study site

    Gdynia

  • Study site

    Olsztyn

  • Urology and Urological Oncology Department and Clinic

    Wroclaw

  • Wojewódzki Szpital Specjalistyczny we Wrocławiu

    Wroclaw

Other trials in Poland

United Kingdom5 sites

  • Study site

    Leeds

  • Guy's & St Thomas NHS Foundation

    London

  • The Royal Marsden NHS Trust

    London

  • University College Hospitals London

    London

  • Study site

    Sutton

Other trials in United Kingdom

Belgium4 sites

  • AZ Maria Middelares

    Ghent

  • UZ Gent

    Ghent

  • Study site

    Leuven

  • Study site

    Roeselare

Other trials in Belgium

Denmark4 sites

  • Study site

    Aalborg

  • Study site

    Aarhus

  • Study site

    Copenhagen

  • Study site

    Herlev

Other trials in Denmark

Hungary3 sites

  • Bajcsy-Zsilinszky Kórház

    Budapest

  • Országos Onkológia Intézet

    Budapest

  • Uzsoki utcai Kórház

    Budapest

Other trials in Hungary

Lithuania2 sites

  • Study site

    Kaunas

  • Study site

    Vilnius

Other trials in Lithuania

About this study

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

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.

Being tested
Tasquinimod, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TasquinimodDrug

    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.

  • PlaceboDrug

    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

Study groups in NCT01732549
Study groupRoleWhat they receive
TasquinimodExperimental1 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.
Receives: Drug: Tasquinimod
PlaceboPlacebo comparator1 capsule daily, taken orally with water and food until disease progression or toxicity or patient's willingness to stop.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Radiological Progression Free Survival [PFS]

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

    Radiological progression was defined

    • Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.

    Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

    • Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions.

    Measured: Every 8 weeks until disease progression documentation (approximately up to 2.5 years)

Secondary outcomes (7)

  1. Overall Survival Based on Number of Subjects Who Died

    Overall survival is defined as the time from randomisation to death due to any cause.

    The number of participants who died is presented since the Median was not reached for this assessment.

    Tasquinimod: Patients censored = 63, Patients at risk (t=0) = 71 Placebo: Patients censored = 67, Patients at risk (t=0) = 73

    Measured: Every 3 months after study treatment stop until death (approximately up to 2.5 years)

  2. Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)

    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.

    Radiological progression was defined

    • Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.

    Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

    • Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions.

    Measured: Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)

  3. Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death

    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].

    Symptomatic progression was defined by the occurrence of pain with documented disease, skeleton related adverse events.

    The median symptomatic PFS for placebo and tasquinimod groups was not reached.

    Tasquinimod: Patients censored = 48, Patients at risk (t=0) = 71 Placebo: Patients censored = 54, Patients at risk (t=0) = 73

    Measured: Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)

  4. Time to Further Anticancer Treatment for Prostate Cancer

    Time from randomisation to further treatment for prostate cancer

    Measured: Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)

  5. Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P)

    End of Study visit (within 14 days of last dose of study treatment)

    Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P

    The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL)

    Measured: Up to End of Study visit (approximately up to 2.5 years)

  6. Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score

    Baseline is defined as last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment)

    The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between treatment groups designed for self-completion by patients consists of two pages [EQ-5 descriptive system and EQ Visual Analogue Scale(VAS)]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS. The respondents are asked to mark health status on the day of the interview on a 10cm vertical scale with end points of 0 to100. There are notes at the both ends of the scale that the bottom rate(0) corresponds to "the worst health you can imagine", and the highest rate(100) corresponds to "the best health you can imagine"

    Measured: Baseline and End-of-study Visit (approximately up to 2.5 years)

  7. Safety Profile of Tasquinimod

    Number of subjects reporting adverse events

    Measured: At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionFeb 2015
  4. Study completionMay 2015

Why it stopped: Development of tasquinimod in prostate cancer discontinued

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01732549
Sponsor's protocol ID
8-55-58102-002
Other IDs
2012-001038-32
Status last verified
Nov 2019
First submitted
24 Oct 2012
Last updated
22 Nov 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29059273

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tasquinimod in people with Metastatic Castrate Resistant Prostate Cancer, run by Ipsen at 58 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in France, Italy, Spain, Czechia, Germany and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Radiological Progression Free Survival [PFS] (time frame: Every 8 weeks until disease progression documentation (approximately up to 2.5 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732549, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.

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