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Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer (TasQ003)

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ClinicalTrials.gov Identifier: NCT02057666
Recruitment Status : Terminated (Development of tasquinimod in prostate cancer discontinued)
First Posted : February 7, 2014
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Ipsen

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Asian Chemo-naïve Patients With Metastatic Castrate-resistant Prostate Cancer Drug: Tasquinimod Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-Blind, Placebo-Controlled Study Of Tasquinimod In Asian Chemo-Naïve Patients With Metastatic Castrate-Resistant Prostate Cancer
Study Start Date : January 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tasquinimod
Main study: 1 capsule (0.25, 0.50 or 1 mg) daily, taken orally once a day with water and food (preferably the main evening meal).
 Drug: Tasquinimod
A patient will initially receive 0.25 mg/day dose which will then be titrated through 0.5 mg/day (from Day 15) to a maximum of 1mg/day (from Day 29). 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 Comparator: Placebo
1 capsule daily, taken orally once a day with water and food (preferably the main evening meal).
 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 (preferably the main evening meal).


Outcome Measures
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Primary Outcome Measures :
  1. Time to Radiological Progression-Free Survival [PFS] [ Time Frame: Every 3 months, up to 3 years ]
    PFS is 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Every 3 months, up to 3 years ]
    Overall survival is defined as the time from randomisation to death due to any cause

  2. Time to Symptomatic PFS based on local assessment [ Time Frame: Every 3 months, up to 3 years ]
    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 occurs first.

  3. Time from randomisation to further treatment for prostate cancer. [ Time Frame: Every 3 months, up to 3 years ]
  4. Quality of Life (QoL) [ Time Frame: Every 3 months, up to 3 years ]
    Quality of Life (QoL) measured by the Functional Assessment of Cancer Therapy Prostate Module (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D).


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (computed tomography [CT] scan/magnetic resonance imaging [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 have been achieved

Exclusion Criteria:

  • 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 NCI-CTCAE v4.03 Grade ≤1. If radiation therapy is applied after Baseline scan, a new Baseline scan needs 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 agonists or antagonists, denosumab (Prolia®) or bisphosphonate (e.g. zoledronic acid), which are allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed
  • Prostate cancer pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy
  • Prostate-Specific Antigen (PSA) >100 ng/mL
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057666


Locations
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China
Beijing, China
Changsha, China
Chengdu, China
Chongqing, China
Guangzhou, China
Hangzhou, China
Nanchang, China
Nanjing, China
Shanghai, China
Shantou, China
Shenyang, China
Soochow, China
Tianjin, China
Wenzhou, China
Wuhan, China
Korea, Republic of
Cheongju, Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Taichung, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Medical Director Uro-Oncology Ipsen
More Information
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02057666    
Other Study ID Numbers: 8-55-58102-003
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases