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Prostatic Neoplasms, Castration-ResistantPhase 3TasQ003NCT02057666

Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer

A Phase 3 study testing Tasquinimod in people with Prostatic Neoplasms, Castration-Resistant, run by Ipsen at 36 sites in 3 countries.

Terminated

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

Official record
Search all trials

Trial summary

The primary objective was to confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC). Read more about this study

Who is it for?
Ages 20 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
146 participants
Where
36 sitesin 3 countries
Study dates
Jan 2014to May 2015
Phase
Phase 3
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 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Asian male aged at least 20 years at the time of signing the informed consent form.
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate.
  • Evidence of metastatic disease (bone and/or visceral), excluding node lesion only, on radiographic examination, whether from bone scan (bone lesions) or other imaging modality (CT scan/MRI).
  • Chemical or surgical castration verified by levels of serum testosterone ≤50 ng/dL (1.75 nmol/L).
  • Evidence of progressive disease after castration levels of testosterone had been achieved, defined by any of the following criteria:
  • Increasing serum Prostate Specific Antigen (PSA) levels, with the most recent value ≥2 ng/mL (increasing levels must have been confirmed by three consecutive PSA measurements, within 15 months prior to the start of study treatment. The time between each PSA test should have been preferably at least 14 days, however a minimum of 7 days was acceptable. The third value was used for study selection).
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  • Progression of soft tissue metastasis documented within 6 weeks prior to randomisation (CT scan or MRI).
  • Progression of bone disease (at least one new bone lesion as measured by bone scan within the 12 weeks prior to the start of study treatment).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Laboratory values as follows:
  • Haemoglobin ≥90 g/L (≥9 g/dL).
  • Absolute neutrophil count ≥1500/μL.
  • Platelets ≥100,000/μL.
  • Serum creatinine ≤1.5 times the upper limit of normal (ULN).
  • Total bilirubin ≤1.5 times ULN.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times ULN (≤5 times ULN if liver metastases were present).
  • Serum amylase ≤ULN (if serum amylase >ULN, pancreatic amylase and serum lipase should have been analysed. If both pancreatic amylase and serum lipase were >ULN, patient excluded).
  • If sexually active with partner of childbearing potential, patient agreed to use adequate contraceptive method (barrier contraceptive with spermicide) while receiving study treatment and until 14 days after the stop of study treatment or had been previously vasectomised.
  • No evidence (within last 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
  • Able to swallow and retain oral medication.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator and to comply with the requirements of the entire study.
  • Able to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.

Who cannot join

  • Cytotoxic chemotherapy for the treatment of prostate cancer within 2 years prior to the start of study treatment.
  • Previous anticancer therapy using radiation, biologics or vaccines and including sipuleucel-T (Provenge®) within 4 weeks prior to the start of study treatment and abiraterone, TAK700 or MDV3100 within 2 weeks prior to the start of study treatment. Before inclusion, abiraterone, TAK700 or MDV3100 related adverse effect must have been resolved to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 Grade ≤1. If radiation therapy was applied after Baseline scan, a new Baseline scan needed to be done at least 4 weeks after the radiation therapy.
  • Therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide e.g. Casodex®) prior to the start of study treatment.
  • Concurrent use of other anticancer agents or treatments, with the exception of ongoing treatment with luteinising hormone-releasing hormone (LHRH) agonists or antagonists, denosumab (Prolia®) or bisphosphonate (e.g. zoledronic acid), which were allowed. Ongoing treatment was to be kept at a stable schedule; however, if medically required, a change of dose, compound, or both was allowed.
  • Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
  • Prostate cancer pain that required ongoing treatment with narcotic analgesics or warranted the initiation of radio- or chemotherapy.
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  • Both of the following criteria:
  • Visceral metastasis.
  • Bone lesions both on and outside of the spinal axis.
  • PSA >100 ng/mL.
  • Ongoing treatment with warfarin.
  • Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
  • Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone was not allowed within 1 year prior to the start of study treatment.
  • Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
  • Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
  • Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs less than 4 weeks prior to the start of study treatment.
  • Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, New York Heart Association (NYHA) class III/IV congestive heart failure, cerebrovascular accident, transient ischaemic attack, or limb claudication at rest, within 6 months prior to start of study treatment, history of venous thrombo-embolic disease within 3 months prior to randomisation and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
  • History of pancreatitis.
  • Known brain or epidural metastases.
  • Known positive serology for human immunodeficiency virus (HIV) (patients with known history of HIV were excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
  • Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who had recovered from hepatitis were allowed to enter the study) with abnormal liver function.
  • Patients with active tuberculosis (TB), or with known, untreated latent TB (country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should have intended to complete the entire course of that therapy).
  • Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could have confounded the ability to interpret data from the study or placed the patient at unacceptable risk if he participated in the study.
  • Any patient who in the opinion of the Investigator should not have participated in the study.

Trial locations and contacts

36 sites in 3 countries.

36 sites in 3 countries

China27 sites

  • Beijing Chao-Yang Hospital Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100370

  • Beijing Hospital of Ministry of Health

    Beijing, Beijing Municipality, 100730

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 61004

  • Sichuan Academy of Sichuan Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • General Hospital Chengdu Military Region of PLA

    Chengdu, Sichuan, 610083

  • Southwest Hospital (the First Affiliated Hospital of Third Military Medical University PLA)

    Chongqing, Chongqing Municipality, 400038

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

  • Guangshou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The First Affiliated Hospital College of Medicine Zhujiang University

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Ruijin Hospital Shanghai Jiaotong University of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Huadong Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

  • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheong Province, 361-711

  • Chonnam National University Hospital

    Gwangju, 501-757

  • Gangnam Severance Hospital

    Seoul, 135-720

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 137-701

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase III, Randomised, Double-Blind, Placebo-Controlled Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer

The primary objective was to confirm the effect of tasquinimod in delaying disease progression or death as compared with placebo in chemo-naïve patients with metastatic castrate-resistant prostate cancer (mCRPC).

Secondary objectives included further evaluation of the safety profile of tasquinimod, comparison of clinical benefits (such as overall survival and symptoms) of tasquinimod with placebo, to evaluate the quality of life impact and to determine the pharmacokinetics of tasquinimod.

Read the detailed description

The study involved a 4-week Screening Period, Baseline Visit (Day 1) where the patient was randomised, followed by a Double Blind Treatment Period. Patients initially received tasquinimod (or corresponding placebo) at a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively. The Double Blind Treatment Period continued until the death of the patient or any criterion for withdrawal from study treatment was reached. Any placebo treated patients with radiological disease progression confirmed by the central imaging assessment, who remained asymptomatic or mildly symptomatic were, at the Investigator's discretion, given the option to continue on active treatment (tasquinimod) during an Open-Label Treatment Period, following the same titration rule described above until progression under active treatment. All other patients stopped study treatment.

An End-of-Study Treatment/Withdrawal Visit was to be performed within 14 days after the last dose of study treatment and patients were then to be followed up every 6 months until 80% of the patients had died or 2 years after the last patient was randomised, whichever occurred last.

A PK ancillary study was to be performed in a subgroup of 12 Asian-Chinese patients before randomisation; however, due to the early termination of this study, only some samples were analysed and no PK analyses were performed.

Being tested
Tasquinimod, Placebo
Keywords
CRPC, Metastatic, Chemotherapy naïve, Chemo-naïve, Prostate cancer, mCRPC, Chemotherapy-naïve, Chemo naïve
Medical subject headings
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

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

  • TasquinimodDrug

    Also called ABR-215050

    A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively.

  • PlaceboDrug

    Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod).

Study groups in NCT02057666
Study groupRoleWhat they receive
TasquinimodExperimentalOne capsule (0.25, 0.50 or 1 mg), taken orally once a day with water and food (preferably the main evening meal).
Receives: Drug: Tasquinimod
PlaceboPlacebo comparatorOne capsule, taken orally once a day with water and food (preferably the main evening meal).
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)

    PFS was defined as the time from the date of randomisation to the date of radiological progression (confirmed by the central imaging assessment) or death due to any cause. Radiological progression was defined by any of the following criteria: progression of soft tissue lesions evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 criteria; progression of bone lesions detected with bone scan according to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria; or radiologically confirmed spinal cord compression or pathological fracture due to malignant progression.

    The primary endpoint was centrally and independently evaluated.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes (6)

  1. Overall Survival

    An overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.

    Measured: From randomisation up to 3 years

  2. Local Assessment of Radiological PFS

    The Investigator was to evaluate radiological disease progression in accordance with the criteria defined for the primary endpoint.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

  3. Time to Symptomatic PFS Based on Local Assessment

    Symptomatic PFS, defined as the time from the date of randomisation to the date of appearance of pain (using pain visual analogue scale (VAS)) at a site with documented disease and analgesic use, or skeletal-related events, or death due to prostate cancer, whichever occurred first.

    Measured: Every 3 months

  4. Time From Randomisation to Further Treatment for Prostate Cancer

    The need for any anti-tumour prostate cancer treatments was to be recorded during the Follow-up Period, with the time to further treatment to subsequently be derived.

    Measured: Every 6 months during the follow-up period

  5. Quality of Life (QoL)

    QoL measured by the Functional Assessment of Cancer Therapy Prostate Module (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D).

    Due to the early termination of the study, a simplified data analysis (primary endpoint and overall survival) was performed to fulfil the requirement from regulatory authorities for early termination studies. Therefore, no analyses were performed on this secondary efficacy endpoint.

    Measured: Every 3 months

  6. Tasquinimod Pharmacokinetic (PK) Profile

    Tasquinimod PK profile:

    1. Following a single 1 mg dose of tasquinimod given to a subgroup of 12 Asian-Chinese patients (ancillary study).
    2. At steady state conditions based on limited sampling strategy.

    Following termination of the study the PK analyses were not performed.

    Measured: Up to 216 hours after a single dose and during the double blind treatment period (Day 15, 29, 57 and 127)

Timeline

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

  1. First posted7 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMay 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
146 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057666
Sponsor's protocol ID
8-55-58102-003
Acronym
TasQ003
Status last verified
Mar 2021
First submitted
6 Feb 2014
Last updated
23 Apr 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tasquinimod in people with Prostatic Neoplasms, Castration-Resistant, run by Ipsen at 36 sites in 3 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 23 inclusion and 24 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 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China, South Korea, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 23 Apr 2021). 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: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 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 NCT02057666.

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 23 Apr 2021.

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