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    Summary
    EudraCT Number:2005-005099-33
    Sponsor's Protocol Code Number:CA165-026
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-02-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2005-005099-33
    A.3Full title of the trial
    A Three Cohort Phase II Trial of BMS-275183 Given Orally on a Twice Weekly Schedule in Pretreated Locally Advanced or Metastatic NSCLC Patients
    A.3.2Name or abbreviated title of the trial where available
    CA165-026
    A.4.1Sponsor's protocol code numberCA165-026
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorBristol Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 nameBMS-275183-01
    D.3.2Product code BMS-275183-01
    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.3.9.1CAS number 355113-98-3
    D.3.9.2Current sponsor codeBMS-275183-01
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Pretreated Locally Advanced or Metastatic Non Small Cell Lung 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 10062042
    E.1.2Term Lung neoplasm
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate.
    E.2.2Secondary objectives of the trial
    To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population. To assess the response duration. To assess the progression free survival time. To assess the overall survival time. To assess the plasma pharmacokinetics PK of BMS-275183 at the recommended dose of 100 mg/m given orally on a twice weekly schedule.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1 Signed written informed consent Target population 2 The subject population will consist of patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who failed only one prior chemotherapy regimen. 3 Prior chemotherapy with a minimum of two chemotherapy cycles given at a full dose. Prior chemo-radiation is not allowed unless the patient received a full dose of chemotherapy concomitantly with the radiation or the concomitant chemo-radiation was preceded or followed by a minimum of two cycles of the same chemotherapy administered at a full dose .. That chemotherapy must be a taxane for cohort I, a platinum based but non taxane containing regimen for cohort II and any chemotherapy regimen and one EGFR-TKI inhibitor compound for cohort III patients. 4 Prior treatment with EGFR-TKI inhibitor is allowed only for patients in cohort 3. Prior treatment with a VEGFr inhibitor is allowed for all the patients. The VEGFr inhibitor cannot be in addition an EGFR inhibitor. 5 Prior chemotherapy may have been administered in adjuvant, neoadjuvant or advanced setting but only one prior chemotherapy regimen is allowed to which the patient must have failed treatment i.e. disease recurrence in adjuvant setting or tumor progression in advanced stages . 6 Patients must have at least one measurable lesion according to the SWOG criteria. 7 Prior anti cancer treatment must have been discontinued at least 3 weeks prior to study enrollment and the patient must have recovered from the acute toxicities of the prior treatment. 8 Prior radiation therapy must be completed at least 2 weeks prior to study enrolment and the patient must have recovered from its toxicities. 9 Prior curative surgery must have been completed at least 10 weeks, and prior palliative surgery must have been completed at least 2 weeks, prior to study enrollment. 10 Performance status of 0 or 1 on the ECOG scale or 90-100 on the Karnofsky scale see Appendix 2 . a Adequate organ function is defined as i Adequate bone marrow function absolute Neutrophil count of at least 1.5 x 10 9/L, platelets 8805; 100 x 10 9 /L, and hemoglobin 8805; 9 g/dl ii Adequate hepatic function Bilirubin less than or equal to the upper limit of normal ULN , AST, ALT 8804; 1.5 times ULN, and alkaline phosphatase 8804; 2.5 ULN iii Renal Plasmatic creatinine 1.5xULN 11 Estimate life expectancy of a least 8 weeks Age and Sex 12 Men and women, age 18 years Women of childbearing potential WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized WOCBP must have a negative serum or urine pregnancy test minimum sensitivity 25 IU/L or equivalent units of HCG within 72 hours prior to the start of study medication.
    E.4Principal exclusion criteria
    Sex and Reproductive Status 1 WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and up to 8 weeks after the study. 2 Women who are pregnant or breastfeeding 3 Women with a positive pregnancy test on enrollment or prior to study drug administration. Target Disease Exceptions 4 Prior brain metastases, unless previously treated adequately, the patient is asymptomatic and no longer requires corticosteroids, and a minimum of 4 weeks has elapsed since the treatment of the brain lesions. Medical History and Concurrent Diseases 5 Second primary malignancy that is detectable at the time of consideration for study enrollment 6 Prior history of a major gastrointestinal surgery or malabsorption that could potentially influence the absorption of BMS-275183 7 Recent significant cardiovascular disease i.e., myocardial infarction, unstable angina within 6 months, or any history of significant degree congestive heart failure with or without medical treatment, any history of clinically significant atrial or ventricular arrhythmias, any history of Grade 2 or 3 heart block . 8 QTc prolongation 500 msec at the baseline 9 Serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient s ability to complete the study 10 Prior treatment with BMS275183 11 Active infection that, in the opinion of the investigator, is not compatible with the conduct of the study. Physical and Laboratory Test Findings 12 Inability or unwillingness to swallow the oral BMS-275183 13 NCI CTC AE Grade 61601; 61661; 61472;2 peripheral neuropathy at study entry. 14 Significant weight loss, i.e. 8805; 10 , over the previous 6 weeks before study entry Allergies and Adverse Drug Reactions Not applicable Prohibited Therapies and/or Medications 15 Concomitant medication with efflux transporter PGP inhibitors such as Benzimidazoles benzimidazoles includes PPIs such as omeprazole, esomeprazole, lansoprazole, pantoprazole or prior medication with such drugs within seven days from study drug administration 16 Concomitant medication with a CYP 3A4 inhibitor or inducer see Appendix 3 . 17 Concomitant medication with Metoclopramide Other Exclusion Criteria 18 Prisoners or subjects who are compulsorily detained involuntarily incarcerated for treatment of either a psychiatric or physical e.g., infectious disease illness must not be enrolled into this study
    E.5 End points
    E.5.1Primary end point(s)
    To assess efficacy of BMS-275183 in pretreated NSCLC patients as measured by the tumor response rate. To further characterize the qualitative and quantitative toxicities of BMS-275183 in the same patient population. To assess the response duration. To assess the progression free survival time. To assess the overall survival time. To assess the plasma pharmacokinetics PK of BMS-275183 at the recommended dose of 100 mg/m given orally on a twice weekly schedule.
    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 No
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) 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) Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-02-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 93
    F.4.2.2In the whole clinical trial 186
    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 Decision2006-11-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-01-29
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