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    Summary
    EudraCT Number:2008-000062-24
    Sponsor's Protocol Code Number:D0810C00021
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-09-22
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-000062-24
    A.3Full title of the trial
    Ensayo fase I/II, abierto, multicéntrico, de AZD2281 oral en combinación con Cisplatino, para valorar la seguridad y tolerabilidad en pacientes con tumores sólidos avanzados, y para valorar la eficacia como terapia neoadyuvante en pacientes con cáncer de mama triple negativo

    A Phase I/II, Open Label, Multi-centre Study of AZD2281 Administered Orally in Combination with Cisplatin, to Assess the Safety and Tolerability in Patients with Advanced Solid Tumours, and to Assess Efficacy in the Neoadjuvant Setting for Patients with Triple Negative Breast Cancer
    A.4.1Sponsor's protocol code numberD0810C00021
    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 SponsorAstraZeneca 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 nameAZD2281 (KU-0059436)
    D.3.4Pharmaceutical form Capsule*
    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 INNolaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeAZD2281 (KU-0059436)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecisplatin
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcisplatin
    D.3.9.3Other descriptive namecisplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tumores sólidos avanzados, cáncer de mama triple negativo

    Advanced Solid Tumours, Triple Negative Breast Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    · Part A/Phase I: The primary objective is to determine the safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with cisplatin to patients with advanced solid tumours.
    · Part B/Phase II: The primary objective is to assess the complete pathological response rates of AZD2281+ cisplatin versus cisplatin alone in the treatment of patients with Triple Negative Breast Cancer in the neoadjuvant setting.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    1. To compare exposure to AZD2281 when given alone and in combination with cisplatin. (Part A/Phase I).
    2. To study the safety and tolerability of AZD2281 in combination with cisplatin in patients with Triple Negative Breast Cancer suitable for curative intent surgery in the neoadjuvant phase. (Part B/Phase II).
    3. To make a preliminary assessment of the anti-tumour activity of AZD2281 when given in combination with cisplatin, by measuring overall response rate (Part A and B)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title of the genetic substudy:
    "A Phase I/II, Open Label, Multi-centre Study of AZD2281 Administered Orally in Combination with Cisplatin, to Assess the Safety and Tolerability in Patients with Advanced Solid Tumours, and to Assess Efficacy in the Neoadjuvant Setting for Patients with Triple Negative Breast Cancer"

    Date of the genetic substudy: 07 July 2008

    Version of the genetic substudy: 1

    Objectives: To obtain an optional blood sample for DNA extraction for future pharmacogenetic analysis and other potential correlative markers of the activity of AZD2281 and drugs taken in combination with AZD2281
    E.3Principal inclusion criteria
    For inclusion in the study subjects must fulfil all of the following criteria:
    1. Fully-informed written consent.
    2. Adequate bone marrow, hepatic and renal function including the following:
    - Haemoglobin ≥9.0 g/dL
    - White blood cell count >3 x 109/L
    - Absolute neutrophil count ≥1.5 x 109/L
    - Platelets ≥100 x 109/L;
    - Total bilirubin ≤1.5 x upper normal limit;
    - AST (SGOT), ALT (SGPT) ≤2.5 x upper normal limit (or ≤5x UNL in the presence of liver metastases);
    - Serum creatinine ≤1.5 mg/dL
    - Creatinine Clearance >50mL/min
    3. Male or female patients, age ≥18 years.
    4. Performance status (PS) ≤2 (ECOG scale).
    5. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
    6. Negative pregnancy test for women of childbearing potential only
    Phase I specific inclusion criteria:
    7. Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent.
    8. Life expectancy of at least 12 weeks.
    9. Patients with measurable or non measurable disease according to RECIST (see Appendix G)
    Phase II specific inclusion criteria:
    10. All tumours must be ER-, PR- and HER-2 negative (HER-2 0,1+ by IHC; HER-2 2+ must be negative by FISH).
    11. Patients with measurable disease on MRI according to appendix G
    12. Breast cancer Stage Clinical T 2-3, N0 1, M0.
    - Patients with stage II or III breast cancer are eligible. This includes T2-3, N0 1, and M0. Cancer in the breast and/or axilla must be equal or greater than 2.0 cm.
    NB Patients with a HER2 negative ipsilateral breast recurrence are NOT eligible unless prior treatment consisted of excision alone for DCIS or breast conserving treatment and hormonal therapy for DCIS or invasive cancer.
    For inclusion in the genetic component of the study, subjects must fulfil the following criterion:
    · Provision of informed consent for genetic research
    If a subject declines to participate in the pharmacogenetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Major surgery within 4 weeks of starting the study.
    2. Co-existing active infection.
    3. Gastrointestinal disorders likely to interfere with absorption of the study drug (e.g. partial bowel obstruction, malabsorption) or with the patient’s ability to take regular oral medication.
    4. Patients requiring treatment with inhibitors or inducers of CYP3A4.
    5. Patients currently experiencing seizures or who were currently being treated with any anti-epileptic for seizures (use of anti-epileptic drugs to control pain is allowed in patients not suffering from seizures unless drug is excluded due to CYP3A4 induction – phenytoin, carbamazapine, phenobarbitone.
    6. Patients who are unable to swallow oral medication.
    7. A positive pregnancy test. Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used (lack of childbearing potential is met by being post-menopausal, being surgical sterile, practicing contraception with an oral contraceptive or other hormonal therapy [eg, hormone implants], intra-uterine device, diaphragm with spermicide or condom with spermicide, or being sexually inactive. Patients and their partners must agree to use one of the above forms of contraception throughout the treatment period and for 3 months after discontinuation of treatment.
    8. Renal dysfunction for which exposure to cisplatin would require dose modification or be completely unsafe (serum creatinine >1.5 mg/dL)
    9. Immunocompromised patients e.g. Patients who are known to be serologically positive for human immunodeficiency virus (HIV).
    10. Patients with active or severe cardiovascular or pulmonary disease, including recent (<6 months) myocardial infarction or deep-venous thrombosis/pulmonary embolism, congestive heart failure, uncontrolled hypertension (systolic blood pressure >180 mm Hg, diastolic blood pressure >105 mm Hg), or steroid-dependent asthma, are ineligible.
    11. Patients with peripheral neuropathy of any etiology that exceeds grade 1 are ineligible.
    12. Patients with uncontrolled diabetes (fasting blood sugar >200 mg/dL) are ineligible.
    13. Any co-existing medical condition that in the investigator’s judgement will substantially increase the risk associated with the patient’s participation in the study e.g. patients with a clinically significant hearing impairment..
    14. Simultaneous participation in any other study involving an investigational medicinal product, or having participated in a study less than 28 days prior to the start of study treatment.
    15. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
    16. Known hypersensitivity to AZD2281 or any of its excipients, cisplatin or other platinum containing compounds
    17. Use of live virus vaccinations within 3 months before or after treatment
    Phase I specific exclusion criteria:
    18.Less than 28 days from active therapy (i.e. any treatment used to treat the disease) or high dose radiotherapy (patients may continue concomitant use of a stable dose of bisphosphonates if used for at least 28 days prior to commencing study treatment and patients may receive palliative radiotherapy for bone disease during the study)
    19.Brain metastases or spinal cord compression, unless irradiated at least 4 weeks before entry and stable without steroid treatment for ≥ 1 week.
    20.Persistent CTCAE grade 2 or greater toxicities (excluding alopecia) caused by prior therapy
    Phase II specific exclusion criteria:
    21.Any prior chemotherapy or radiotherapy.
    22.Patients must not have any other pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by the NCI criteria.
    23.Patients with a prior history of malignancy treated without curative intent.
    24.Evidence of metastatic disease
    E.5 End points
    E.5.1Primary end point(s)
    Clinical endpoints (Phase II):

    Objective response rate:
    The primary objective of the Phase II part of the study is to compare complete pathological response rates between the 2 treatment groups.
    Surgical breast and axillary node resection specimens will be evaluated for pathologic tumour response according to NSABP guidelines (Fisher et al 2002). Patients will be considered in pCR if no invasive cancer or only in-situ cancer is observed in the breast specimen. The above system does not take into account the nodal status to define pCR. The Miller-Payne pathologic system will be use to code response. All study samples will be reviewed by two breast pathologists expert in the Miller-Payne system to provide codes for response analysis (Part B/Phase II only).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    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
    The end of the study is defined as when the database lock is performed and no patients are receiving ongoing treatment with AZD2281.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 144
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The end of the study is defined as 30 days after the last patient undergoes surgery. Patients will not continue to be treated per protocol after surgery and will be free to receive “best practice” dependent on the course of their disease.
    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 Decision2008-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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