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    Summary
    EudraCT Number:2011-004558-24
    Sponsor's Protocol Code Number:CC-115-ST-001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-08-14
    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 ConcernedFrance - ANSM
    A.2EudraCT number2011-004558-24
    A.3Full title of the trial
    A PHASE 1A/1B, MULTICENTER, OPEN LABEL, DOSE-FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF THE DUAL DNA-PK AND TOR KINASE INHIBITOR, CC-115,
    ADMINISTERED ORALLY TO SUBJECTS WITH ADVANCED SOLID TUMORS, NON-HODGKIN’S LYMPHOMA OR MULTIPLE MYELOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN EARLY PHASE CLINICAL STUDY AT SEVERAL RESEARCH CENTERS TO
    EXPLORE THE SAFETY, BLOOD LEVELS AND ANTITUMOR EFFECTS USING
    DIFFERENT DOSES OF CC-115 TAKEN BY MOUTH FOR PATIENTS WITH
    ADVANCED SOLID CANCER OR EITHER NON-HODGKIN LYMPHOMA OR
    MULTIPLE MYELOMA.
    A.4.1Sponsor's protocol code numberCC-115-ST-001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinicalTrialDisclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th Street, Building 70, Suite 300
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1-888-260-1599
    B.5.5Fax number+1 913-451-3459
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    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 nameCC-115
    D.3.2Product code CC-115
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCC-115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25 to mg
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 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 nameCC-115
    D.3.2Product code CC-115
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCC-115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0 to mg
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 nameCC-115
    D.3.2Product code CC-115
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCC-115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0 to mg
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Subjects with advanced solid tumors, non-hodgkin lymphoma (NHL) and
    multiple myeloma (MM).
    E.1.1.1Medical condition in easily understood language
    Certain types of cancer that do not respond to treatment or for whom no standard anticancer therapy exists
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Determine the safety and tolerability of CC-115 when administered orally and to define the Non-Tolerated Dose and the Maximum Tolerated Dose.
    2. Determine the PharmacoKinetics of CC-115.
    E.2.2Secondary objectives of the trial
    1. Evaluate the extent of inhibition of phosphorylation of S6RP and/or 4E-BP1 for mTORC1 activity and AKT and/or other relevant biomarkers for mTORC2 activity, in blood, skin and/or tumor biopsies/aspirates, when available before and during treatment with CC-115.
    2. Evaluate the inhibition of DNA-PK activity in skin samples irradiated by UV light and/or tumor biopsies/aspirates using pDNA-PK S2056 and/or other relevant biomarkers for DNA damage pathways before and during CC-115 treatment.
    3. Provide information on the efficacy of CC-115.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Please refer to protocol section 7.2 for the complete inclusion criteria, which are summarized below.

    •Men and women, 18 years or older, with histological or cytological confirmation of advanced unresectable solid tumors, non-hodgkin’s lymphoma (NHL), or multiple myeloma (MM), including those who have progressed on (or not been able to tolerate) standard anticancer therapy or for whom no other conventional therapy exists. Ewing’s sarcoma (ES) subjects may be 12 years or older.
    •Consent to screening tumor biopsy (Part A optional; Part B mandatory except as specified for individual tumor types)
    •ECOG PS 0 or 1
    •Laboratory values: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L; hemoglobin (Hgb) ≥ 9 g/dl; platelets ≥ 100 x 10^9/L; potassium within normal range or correctable with supplements; AST/SGOT and ALT/SGPT ≤ 2.5 x ULN or ≤ 5.0 x ULN if liver tumor is present; serum total bilirubin ≤ 1.5 x ULN; serum creatinine ≤ 1.5 x ULN or 24-hr clearance ≥ 50 mL/min; negative serum or urine pregnancy test within 72 hrs before starting study treatment in females of childbearing potential

    Dose expansion part (Part B) of the protocol only:
    •Consent to retrieve formalin-fixed, paraffin-embedded (FFPE) archival tumor tissue; an exemption waiver may be granted by the Sponsor in exceptional circumstances.
    •Histologically-confirmed tumors of the following types. Please refer to the specific inclusion criteria applicable to each tumor type, described in protocol section 7.2, which are in addition to, or supersede, the above criteria where applicable:
    -Glioblastoma multiforme (GBM) or gliosarcoma, excluding WHO Grade IV oligoastrocytoma
    -Head & neck squamous cell cancer (HNSCC)
    -Triple negative breast cancer (TNBC)
    -Hormone receptor-positive breast cancer (HRPBC)
    -Castration-resistant prostate cancer (CRPC)
    -Ewings Family of Sarcomas
    E.4Principal exclusion criteria
    Please refer to protocol section 7.2 for the complete exclusion criteria, which are summarized below.

    •Symptomatic central nervous system metastases
    •Known acute or chronic pancreatitis
    •Any peripheral neuropathy ≥ NCI CTCAE grade 2
    •Persistent diarrhea or malabsorption ≥ NCI CTCAE grade 2, despite medical management. Impaired ability to swallow
    •Impaired cardiac function or clinically significant cardiac diseases, including any of the following: LVEF < 45% as determined by MUGA scan or ECHO; complete left bundle branch, or bifasicular, block; congenital long QT syndrome; persistent or history of clinically meaningful ventricular arrhythmias or atrial fibrillation; QTcF > 460 msec on screening ECG (mean of triplicate recordings); unstable angina pectoris or myocardial infarction ≤ 3 months prior to starting CC-115; other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mmHg)
    •Diabetes mellitus on active treatment, or subjects with either fasting blood glucose (FBG) ≥ 126 mg/dL (7.0 mmol/L), or HbA1c ≥ 6.5%
    •Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol
    •Prior systemic cancer-directed treatments or investigational modalities ≤ 5 half lives or 4 weeks, whichever is shorter, prior to starting study drug or who have not recovered from side effects of such therapy
    •Major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
    •Pregnancy or breast feeding
    •Adults of reproductive potential not employing two forms of birth control (defined in protocol section 7.2):
    •Known HIV infection
    •Known chronic hepatitis B or C virus (HBV/HCV) infection, unless this is comorbidity in subjects with HCC
    •Concurrent active second malignancy for which the subject is receiving therapy, excluding non-melanomatous skin cancer or carcinoma in situ of the cervix

    Dose expansion part (Part B) of the protocol only:
    •Prior treatment with agents targeting both mTOR complexes (dual TORC1+TORC2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated TORC1 inhibitors (e.g., rapalogs) is allowed in both parts of this study.
    E.5 End points
    E.5.1Primary end point(s)
    1. The following safety endpoints: DLTs, NTD and MTD, evaluated using the NCI CTCAE criteria Version 4.
    2. PK endpoints: Cmax, AUC, tmax, t1/2, CL/F, Vz/F and Accumulation Index of CC-115.
    E.5.1.1Timepoint(s) of evaluation of this end point
    DLT/NTD or MTD are not time-related endpoints.
    During the Part A Cycle 1, DLTs and all available safety information will be reviewed on an ongoing basis by the Investigators and sponsor and summarized at the conclusion of each dose level. After completion of each dose cohort, the SRC will review the summarized data to determine the next step. Complete safety data for the Part A Cycle 1 will be summarized when all subjects have completed the first 28-day cycle.
    Blood draws for PK assessments will be taken on day 1,2,15 and 22 during cycle 1, blood draws will be taken at C1D1, C1D15 for all patients and in addition at C1D2 and C1D22 only for Ewings Sarcoma patients under 18 and for adult patients in US
    E.5.2Secondary end point(s)
    1.Biomarker inhibition, determined by change in the levels of phosphorylation of S6RP, and/or 4E-BP1, and/or AKT, and/or other relevant biomarkers in blood, skin and/or tumor biopsies/aspirates, when available.
    2.Inhibition of UV-stimulated DNA-PK activity determined by levels of pDNA-PK and/or other relevant biomarkers in skin and/or tumor biopsies/aspirates, when available.
    3.Antitumor efficacy, determined by response rates of each tumor type using tumorappropriate response criteria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Blood for PD Biomarkers (Part B/US only);
    2. UV-stimulated skin biopsy (US only);
    3. Antitumor efficacy - Efficacy will be analyzed by each tumor type once all subjects have withdrawn from the study or completed 6 cycles.
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Spain
    United States
    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
    LVLS: final safety assessment 28 +/- 2 days after last dose of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 8
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 100
    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 study doctor will talk to the subject about his/her continued care, what other treatment would be available to the subject, and if any other tests are needed. The doctor may also discuss continued follow-up and further data collection related to the subject’s health, such as medical treatment or laboratory results obtained through a simple review of his/her charts.
    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 Decision2012-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-18
    P. End of Trial
    P.End of Trial StatusOngoing
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