E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041071 |
E.1.2 | Term | Small cell lung cancer stage unspecified |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The purpose of this study is to determine the multidose safety, tolerability, dose limiting toxicities (DLTs), and the maximally tolerated dose (MTD) of BMS-986012 administered as monotherapy in subjects with relapsed or refractory small cell lung cancer (SCLC). |
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E.2.2 | Secondary objectives of the trial |
• Pharmacokinetics parameters
• Anti-drug antibody to BMS-986012
• Response rate as assessed by RECIST v1.1
• QTcF prolongation as measured by changes in abnormal QTcF
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetics Blood Sample Amendment 01 (site-specific)- dated 09-Jun-2014
The objective of this Amendment is to permit the collection and storage of blood samples for use in future exploratory pharmacogenetic research. Bristol-Myers Squibb will use DNA obtained from the blood sample and health information collected from the main clinical trial, CA001030, to study the association between genetic variation and drug response. Bristol-Myers Squibb may also use the DNA to study the causes and further progression of small cell lung cancer (SCLC).
Samples from this study may also be used in conjunction with pharmacogenetic research results from other clinical studies to accomplish this objective |
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E.3 | Principal inclusion criteria |
• Histological or cytological confirmed SCLC
• Performance Status 0-1
• Adequate organ function
• Measurable disease
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E.4 | Principal exclusion criteria |
• Known or suspected brain metastasis
• Small cell cancer not lung in origin
• Significant or acute medical illness
• Uncontrolled or significant cardiac disease
• Infection
• > Grade 2 peripheral neuropathy
• Concomitant malignancies
• HIV related disease or known or suspected HIV+
• Hepatitis B or C infection
• ECG abnormalities as defined by the protocol
• Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), as appropriate |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Weekly for the 1st and 2nd 21-day cycles, then once every 3 weeks during study treatment, at end of treatment and every 30 days during clinical follow-up until resolution of adverse events or 100 days after the last dose of study medication |
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E.5.2 | Secondary end point(s) |
• Pharmacokinetics parameters
• Anti-drug antibody to BMS-986012
• Response rate as assessed by RECIST v1.1
• QTcF prolongation as measured by changes in abnormal QTcF
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Cmax/ Tmax/ AUC(TAU)/ Ctau of BMS-986012 at multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up
• Area under concentration-time curve from time 0 to the time of the last sample collected in the dosing interval [AUC(0-T)] of BMS-986012 at multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up
• Occurrence of specific ADA to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
• Tumor assessments using RECIST v1.1 approximately every 6 weeks until disease
• Changes in the QTcF after BMS-986012 administration at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 9 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Canada |
Korea, Republic of |
Netherlands |
United States |
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E.8.7 | Trial 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
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Last Patient Last Follow-Up Visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | 17 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 4 |