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    Summary
    EudraCT Number:2007-003470-26
    Sponsor's Protocol Code Number:07TASQ08
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-08-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2007-003470-26
    A.3Full title of the trial
    Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients with Metastatic Castrate-Resistant Prostate Cancer. Final Protocol dated 2007-06-19, Protocol Amendment 1 dated 2007-08-06, Protocol Amendment 2 dated 2007-08-16, Protocol Amendment 3 dated 2007-10-31, Protocol Amendment 4 dated 2007-12-17, Protocol Amendment 5 dated 2008-04-14, Protocol Amendment 6 dated 2008-09-09, Protocol Amendment 7 dated 2009-04-15
    A.4.1Sponsor's protocol code number07TASQ08
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorActive Biotech Research AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameABR-215050
    D.3.2Product code ABR-215050
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTasquinimod
    D.3.9.2Current sponsor codeABR-215050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTasquinimod
    D.3.9.3Other descriptive nameABR-215050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTasquinimod
    D.3.9.3Other descriptive nameABR-215050
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of ABR-215050 vs. placebo in asymptomatic patients with metastatic CRPC, as measured by the proportion of patients who have not progressed at 6 months.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the effect of ABR-215050 vs. placebo in asymptomatic patients with metastatic CRPC on:
    • Time to symptomatic progression
    • Safety and tolerance
    • Tumor response rate in patients with measurable disease
    • Impact on bone metastases
    • Progression free and overall survival
    • Quality of life
    • PSA constructs
    • Molecular markers of angiogenesis and bone turnover
    • Pharmacokinetics of ABR215050
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    In order to participate in the study patients must be (have):
    1. Age ≥18 years at the time of signing the informed consent form.
    2. Histologically confirmed diagnosis of adenocarcinoma of the prostate.
    3. Asymptomatic metastatic CRPC (VAS pain score ≤3). The patient may take non-opioid analgesics for non-cancer pain discomfort.
    4. Evidence of metastatic disease from CT or Bone scan
    5. Evidence of progressive disease after castration levels of testosterone have been achieved defined by any of the following criteria:
    • Increased serum prostate-specific antigen (PSA) levels
    (Confirmed by 3 consecutive PSA measurements within 1 year with at least 14 days between each measurement)
    • Progression of bidimensionally measurable soft tissue (nodal) metastasis:
    (CT scan or MRI)
    • Progression of bone disease:
    (New bone lesions by bone scan within the past 12 weeks).
    6. Castrate levels of serum testosterone (less than or equals to 50 ng/dL or 1.7 nmol/L. Testosterone levels will not be required for patients who have had bilateral orchiectomy).
    7. Karnofsky score 70-100
    8. Laboratory values as follows
    • Hb ≥ 90g/L (more than or equals to 9 g/dL)
    • Serum creatinine ≤ 1.5 times ULN
    • Total bilirubin ≤ 1.5 times ULN
    • AST (SGOT) / ALT (SGPT) ≤ 2.5 times ULN
    • Serum amylase less than or equals to ULN. (If serum amylase more than ULN, pancreatic amylase and serum lipase should be analyzed. If both pancreatic amylase and serum lipase is more than ULN, exclude patient)
    9. Patient if sexually active with partner of child bearing potential will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug.
    10. No evidence (≥ 5 years) of prior malignancies (except successfully treated basal cell, squamous cell carcinoma of the skin)
    11. Ability to administer and retain oral medication
    12. Able to adhere to the study visit schedule and other protocol requirements.
    E.4Principal exclusion criteria
    1. Prior cytotoxic chemotherapy within 3 years.
    2. Previous anticancer therapy using biologics or vaccines within the last 6 months. Previous treatment with bevacizumab is not allowed.
    3. Any treatment modalities, involving radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study.
    4. Myocardial infarction or any acute coronary syndrome within one year or current uncontrolled arrhythmias, symptomatic uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled hypertension.
    5. History of pancreatitis.
    6. Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
    7. Concurrent use of other anti-cancer agents or treatments (a stable dose of LHRH agonists, bicalutamide (e.g. Casodex) and/or other antiandrogens is allowed).
    8. Known brain metastases.
    9. Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
    10. Concomitant systemic treatment with warfarin and/or corticosteroids corresponding to a prednisolone dose above 5 mg/day.
    11. Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 14 days prior to inclusion.
    12. Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
    13. Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is proportion of patients with disease progression (DP) at 6 months, defined as any one or more of the following:
    • Onset of tumor-related cancer pain:
    o Narcotic analgesics required for control of tumor-related pain
    Progression by pain criteria is based on pain due to prostate cancer requiring
    one or more of the following palliative interventions:
    Opioid Therapy: Intravenous, intramuscular or subcutaneous opioid therapy administered as a single dose; an increased amount of oral or transdermal opioid analgesic use administered for 10 out of 14 consecutive days, and/or requiring Radionuclide or Radiation therapy.
    Evidence of disease at the site of pain is required. Pain requiring only nonopioid analgesics will not be considered disease progression.
    o VAS [pain] rating >4 due to cancer pain on two consecutive ratings on different days
    • Measurable disease progression:
    o At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions
    • Bone metastases or other non-target lesions:
    o Worsening bone scan as evidenced by the appearance of 2 or more skeletal lesions that are not felt to be consistent with tumor flare.
    -Progressive disease in bone scan at 3 months needs to be confirmed by second scan (6 weeks later) and for progressive disease at least one additional lesion has to be observed in the confirmatory scan.
    o Appearance of new metastatic lesions outside of the bone
    o Unequivocal progression of existing non-target lesions

    • Need for radiotherapy or surgery for pathological fracture or spinal cord compression.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-18
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